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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, continuous, minimal ventilatory support, facility use
Regulation Description Continuous ventilator.
Product CodeMNT
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BREAS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
  1.  K240779  Vivo 3
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MEKICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 DRE Medical Group Inc II Jun-29-2023
2 Philips Respironics, Inc. I Jul-02-2025
3 Philips Respironics, Inc. I May-24-2024
4 Philips Respironics, Inc. I Sep-28-2023
5 Philips Respironics, Inc. II May-21-2021
6 ResMed Ltd. I Feb-07-2020
7 Respironics California, LLC I Apr-18-2022
8 Respironics California, LLC I Feb-25-2022
9 Respironics California, LLC I Jul-22-2021
10 Respironics California, LLC II Feb-19-2021
11 Respironics California, LLC II Jan-22-2021
12 Respironics California, LLC II Jan-22-2021
13 Respironics California, LLC II Mar-31-2020
14 Respironics California, LLC II Mar-02-2020
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