ZOLL MEDICAL CORPORATION

FDA Device Registration & Listing · CHELMSFORD, MA, US · Registration 1220908

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1220908
FEI Number
1220908
Entity Name
ZOLL MEDICAL CORPORATION
City/State/Country
CHELMSFORD, MA, US
Establishment Address
269 MILL ROAD, CHELMSFORD, MA 01824, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ZOLL Medical Corporation (Owner Number: 1220908)
Owner / Operator Contact Address
269 MILL ROAD, Chelmsford, MA 01824, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K031745
PMA Number
N/A

All Registered Proprietary Names

3100A High Frequency Oscillating Ventilator 3100B High Frequency Oscillating Ventilator LTV 1200 MR LTV 1100 Ventilator LTV2 LTV 2200 MRI Roll Stand Roll Stand ZOLL AUTOCLAVABLE EXTERNAL PADDLES ZOLL AUTOCLAVABLE INTERNAL HANDLES ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES LTV Series with Heated Breathing Circuit ACCUVENT SENSOR DISPOSABLE FLOWTUBE, ACCUVENT FLOW SENSOR CONNECTOR, ACCUVENT LTV 1200 Ventilator Neonate Cuff and Adapter Kit ZOLL ePCR iOS Eagle II AEV EMV+ Special Medical Emergency Evacuation Device (SMEED) INFANT FLOW LP NASAL MASKS, EXTRA LARGE INFANT FLOW LP, GENERATOR SET W/O PRONGS, 1EA INFANT FLOW LP NASAL PRONGS, MEDIUM INFANT FLOW LP NASAL PRONGS,EXTRA SMALL INFANT FLOW LP NASAL MASKS, LARGE INFANT FLOW LP, GENERATOR KIT W/RT132 CIRCUIT, 20PK Infant Flow LP System INFANT FLOW LP, GENERATOR KIT W/RT132 CIRCUIT, 10PK INFANT FLOW LP NASAL PRONGS, EXTRA LARGE INFANT FLOW LP, GENERATOR SET W/O PRONGS, 10PK INFANT FLOW LP, GENERATOR SET, 1 EA INFANT FLOW LP NASAL PRONGS, LARGE INFANT FLOW LP NASAL MASKS, MEDIUM INFANT FLOW LP NASAL MASKS, SMALL INFANT FLOW LP NASAL MASKS, EXTRA SMALL INFANT FLOW LP NASAL PRONGS, SMALL INFANT FLOW LP, GENERATOR SET, 10PK

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LSZ Ventilator, High Frequency Unknown Class 3 N/A 2024-11-13
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2024-11-13
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2024-11-13
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2024-10-29
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2024-11-13
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2016-10-12
PIZ Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve Unknown Class 3 N/A 2019-11-21
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-11-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-11-09
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-09
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-11-09
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-11-09
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-11-09
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-09
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2022-11-09
FRN Pump, Infusion General Hospital Class 2 880.5725 2018-10-25
DQA Oximeter Cardiovascular Class 2 870.2700 2008-03-19
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) Cardiovascular Class 2 870.5550 2008-03-19
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2008-03-19
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2008-03-19
LIX Aid, Cardiopulmonary Resuscitation Cardiovascular Class 2 870.5210 2008-03-19
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2008-03-19
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2026-05-07
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2013-03-22
BXP Transducer, Gas Flow Anesthesiology Class 1 868.2885 2026-05-12
LIX Aid, Cardiopulmonary Resuscitation Cardiovascular Class 2 870.5210 2013-03-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-03-22
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2013-03-22
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) Cardiovascular Class 2 870.5550 2013-03-22
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2013-03-22
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-03-22
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2013-03-22
DQA Oximeter Cardiovascular Class 2 870.2700 2013-03-22
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2013-03-22
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) Cardiovascular Class 2 870.5550 2013-03-22
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-03-22
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2013-03-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-03-22
DQA Oximeter Cardiovascular Class 2 870.2700 2013-03-22
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2013-03-22
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2013-03-22
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2024-11-13
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2022-12-19
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2019-11-21
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2023-08-16
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2014-01-06
BTA Pump, Portable, Aspiration (Manual Or Powered) General, Plastic Surgery Class 2 878.4780 2017-05-17
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2017-09-18
DQA Oximeter Cardiovascular Class 2 870.2700 2017-09-18
FOX Stand, Infusion General Hospital Class 1 880.6990 2016-10-12
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2026-05-07

Official Correspondent

Paul Dias

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZOLL Medical Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1218058 ZOLL Medical Corporation Pawtucket, RI, US
2112020 ZOLL Medical Corporation DEERFIELD, WI, US
2021710 ZOLL Palm Springs Palm Springs, CA, US
3038259592 ZOLL MEDICAL CORPORATION Wilmington, MA, US
3029871637 ZOLL International Holding B.V. Elst Gelderland, NL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K051895 Datex-Ohmeda, Inc. GE DATEX-OHMEDA ENGSTROM CARESTATION 2005-09-27
K082966 Covidien, Formerly Nellcor Puritan Bennett, Inc. PB 540 VENTILATOR 2008-10-31
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07
K071802 Mammendorfer Institut Fur Physik Und Medizin GmbH TESLA GUARD, MODEL EFT G04 2007-11-09
K124061 Invivo Corporation MRI PATIENT MONITORING SYSTEM (MODEL 865214) 2013-02-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2015 Respironics California Inc 2
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011 Draeger Medical Systems, Inc. 2
Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015 Nellcor Puritan Bennett Inc. (dba Covidien LP) 2
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015 Nellcor Puritan Bennett Inc. (dba Covidien LP) 2
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022 Covidien Llc 2
Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220908. Last updated year: 2026. Please use registration number 1220908 when referencing this establishment in official correspondence.
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