CRITICARE TECHNOLOGIES, INC.

FDA Device Registration & Listing · Warwick, RI, US · Registration 3012238587

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
3012238587
FEI Number
3012238587
Entity Name
CRITICARE TECHNOLOGIES, INC.
City/State/Country
Warwick, RI, US
Establishment Address
333 Strawberry Field Rd, Suite 11, Warwick, RI 02886, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Criticare Technologies, Inc. (Owner Number: 10051461)
Owner / Operator Contact Address
333 Strawberry Field Rd, Suite 11, Warwick, RI 02886, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K884216
PMA Number
N/A

All Registered Proprietary Names

eQuality nGenuity Vitalcare / eQuality

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2016-03-22
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2016-03-22
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2016-03-22
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2016-03-22

Official Correspondent

John Haefele

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Criticare Technologies, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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3013418500 Quintana Supply, a division of Thomas Scientific Haverhill, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012238587. Last updated year: 2026. Please use registration number 3012238587 when referencing this establishment in official correspondence.
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