MAQUET CRITICAL CARE AB

FDA Device Registration & Listing · SOLNA Stockholm, SE · Registration 8010042

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
8010042
FEI Number
3002808128
Entity Name
MAQUET CRITICAL CARE AB
City/State/Country
SOLNA Stockholm, SE
Establishment Address
ROENTGENVAGEN 2, SOLNA Stockholm S-17154, SE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Maquet Critical Care AB (Owner Number: 8010042)
Owner / Operator Contact Address
ROENTGENVAGEN 2, SOLNA, SE-AB SE-17154, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220703
PMA Number
N/A

All Registered Proprietary Names

Absorber FLOW-i Servo Guard Edi Catheter ENFit MR850 Watertrap reusable Servo-u/n Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 Miniflow adapter Nasal prongs size XS, S, M, M-wide, L, XL, L-wide Breathing Bag Anesthesia, Disposable Breathing Bag set Anesthesia, Reusable Breathing Bag Anesthesia, Reusable SERVO-U/n Servo Humidifier 173 Servo Humidifier 172 Servo Humidifier 163 Servo Humidifier 162 Servo Humidifier 161 Servo-air Lite Ventilator System F&P 950 Respiratory humidifier

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BSF Absorber, Carbon-Dioxide Anesthesiology Class 1 868.5310 2015-10-16
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2014-06-27
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2008-02-19
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2015-11-19
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2017-03-31
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2017-03-31
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2015-10-27
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2014-06-27
BYH Drain, Tee (Water Trap) Anesthesiology Class 1 868.5995 2012-08-31
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2015-12-14
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2015-08-20
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2015-12-14
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2019-03-27
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2021-04-21
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2014-06-27
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2015-05-28
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2012-08-31
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2015-05-28
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2014-06-27
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2015-05-28
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2015-12-22
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2013-06-26
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2023-08-14
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2014-07-01
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2026-06-08

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

Maquet Critical Care AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003263092 PULSION MEDICAL SYSTEMS SE Feldkirchen Bavaria, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K962045 Mallinckrodt Medical ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 1996-11-26
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
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28
K970478 Marquest Medical Products, Inc. SCT 3000 HEATED HUMIDIFIER 1997-07-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2008 Datex Ohmeda, Inc 1
GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010042. Last updated year: 2026. Please use registration number 8010042 when referencing this establishment in official correspondence.
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