Product Code: CBK


Products Classified as CBK

100Ventilator, Continuous, Facility UseContinuous Ventilator.

Total Product Life Cycle (TPLC) Devices

100Ventilator, Continuous, Facility UseContinuous Ventilator.

FDA Consensus Standards

Ventilator, Continuous, Facility Use [36713]21 CFR §868.5895 🔎
Ventilator, Continuous, Facility Use [36710]21 CFR §868.5895 🔎
Ventilator, Continuous, Facility Use [36711]21 CFR §868.5895 🔎
Ventilator, Continuous, Facility Use [36890]21 CFR §868.5895 🔎
Ventilator, Continuous, Facility Use [38929]21 CFR §868.5895 🔎
Ventilator, Continuous, Facility Use [31596]21 CFR §868.5895 🔎
Ventilator, Continuous, Facility Use [36889]21 CFR §868.5895 🔎

Pre-market Notifications for CBK

K210384CARESCAPE R860Datex-Ohmeda, Inc.
K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare Ltd
K202970Ventway SparrowInovytech Medical Solutions Ltd.
K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB
K201658Hamilton-C6Hamilton Medical AG
K201306HAMILTON-C3Hamilton Medical AG
K201082LTV2 Series VentilatorsVyaire Medical Inc
K193228Hamilton-G5Hamilton Medical AG
K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB
K192307Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden OrangeMed, Inc.
K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-VentedSleepnet Corporation
K183364BellavistaImtmedical AG
K181695Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden OrangeMed, Inc.
K181216HAMILTON-T1, HAMILTON-C1Hamilton Medical AG
K181166Trilogy EvoRespironics Inc.

Global Unique Device Identification Database

00606959023109VENTILATOR, CONTINUOUS, FACILITY USE
00606959023093VENTILATOR, CONTINUOUS, FACILITY USE
00606959023086VENTILATOR, CONTINUOUS, FACILITY USE
00606959023079VENTILATOR, CONTINUOUS, FACILITY USE
00606959023062VENTILATOR, CONTINUOUS, FACILITY USE
00606959023055VENTILATOR, CONTINUOUS, FACILITY USE
00606959022805VENTILATOR, CONTINUOUS, FACILITY USE
00606959022775VENTILATOR, CONTINUOUS, FACILITY USE
00606959022706VENTILATOR, CONTINUOUS, FACILITY USE
00606959022171VENTILATOR, CONTINUOUS, FACILITY USE
00606959022096VENTILATOR, CONTINUOUS, FACILITY USE
00606959022065VENTILATOR, CONTINUOUS, FACILITY USE
00606959022058VENTILATOR, CONTINUOUS, FACILITY USE
00606959021662VENTILATOR, CONTINUOUS, FACILITY USE
00606959021082VENTILATOR, CONTINUOUS, FACILITY USE

Maude Adverse Events

VELA VENTILATORVYAIRE MEDICAL2020-03-31
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL2020-03-31
SAVINADR?GERWERK AG & CO. KGAA2020-03-31
SAVINA SYSTEMDRAEGERWERK AG & CO. KGAA2020-03-31
EVITA XLDR?GERWERK AG & CO. KGAA2020-03-31
TRILOGY100RESPIRONICS INC2020-03-31
TRILOGY100RESPIRONICS INC2020-03-31
TRILOGY100RESPIRONICS INC2020-03-31
TRILOGY 100RESPIRONICS INC2020-03-31
UNI-VENT, MODEL 731ZOLL MEDICAL CORPORATION2020-03-31
UNI-VENT, MODEL 731ZOLL MEDICAL CORPORATION2020-03-31
UNI-VENT, MODEL 731ZOLL MEDICAL CORPORATION2020-03-31
ENGSTROMDATEX-OHMEDA, INC.2020-03-31
UNI-VENT, MODEL 731ZOLL MEDICAL CORPORATION2020-03-31
CARESCAPE R860DATEX-OHMEDA, INC.2020-03-31
TRILOGY 100RESPIRONICS, INC.2020-03-31
TRILOGY O2RESPIRONICS, INC.2020-03-31
TRILOGY O2RESPIRONICS, INC.2020-03-31
TRIILOGY 100RESPIRONICS, INC.2020-03-31
TRILOGY 100RESPIRONICS, INC.2020-03-31
TRILOGY 202RESPIRONICS INC2020-03-31
TRILOGY100RESPIRONICS INC2020-03-31
TRILOGY 202RESPIRONICS INC2020-03-31
TRILOGY100RESPIRONICS INC2020-03-31
TRILOGY 202RESPIRONICS INC2020-03-31
TRILOGY 202RESPIRONICS, INC2020-03-31
TRILOGY 202RESPIRONICS, INC2020-03-31
TRILOGY 100RESPIRONICS, INC2020-03-31
TRILOGY 100RESPIRONICS, INC2020-03-31
TRILOGY 100RESPIRONICS, INC2020-03-31
TRILOGY 202RESPIRONICS, INC2020-03-31
TRILOGY O2RESPIRONICS, INC2020-03-31
TRILOGY 100RESPIRONICS, INC2020-03-31
OXYLOG 3000DRAEGERWERK AG & CO. KGAA2020-03-31
SERVO-UMAQUET CRITICAL CARE AB2020-03-31
ESPIRIT V1000PHILIPS NORTH AMERICA LLC2020-03-30
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL2020-03-30
UNI-VENT, MODEL 731ZOLL MEDICAL CORPORATION2020-03-30
CARESCAPE R860DATEX-OHMEDA, INC.2020-03-30
UNI-VENT, MODEL 731ZOLL MEDICAL CORPORATION2020-03-30
TRILOGY O2RESPIRONICS INC.2020-03-30
TRILOGY100RESPIRONICS INC2020-03-30
TRILOGY100RESPIRONICS INC2020-03-30
TRILOGY 100RESPIRONICS INC.2020-03-30
CARESCAPE R860DATEX-OHMEDA, INC.2020-03-30
ENGSTROMDATEX-OHMEDA, INC.2020-03-30
VELA VENTILATORVYAIRE MEDICAL2020-03-29
AVEA VENTILATORVYAIRE MEDICAL2020-03-29
VELA VENTILATORVYAIRE MEDICAL2020-03-29
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL2020-03-29

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