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FDA 510(k)

V*CARE MANUAL RESUSCITATOR

K-Number: K012842 · 2001-09-18

ApplicantVentlab Corp.
Decision Date2001-09-18
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

V*CARE MANUAL RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ventlab Corp.. It received FDA 510(k) clearance on 2001-09-18 under 510(k) number K012842. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V*CARE MANUAL RESUSCITATOR?

V*CARE MANUAL RESUSCITATOR is a medical device that received FDA 510(k) clearance on 2001-09-18. The listed applicant is Ventlab Corp.. The 510(k) number is K012842.

When did V*CARE MANUAL RESUSCITATOR receive FDA 510(k) clearance?

V*CARE MANUAL RESUSCITATOR received FDA 510(k) clearance on 2001-09-18, under 510(k) number K012842.

Who is the listed applicant for V*CARE MANUAL RESUSCITATOR?

The FDA 510(k) record lists Ventlab Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V*CARE MANUAL RESUSCITATOR?

The FDA product code for V*CARE MANUAL RESUSCITATOR is BTM.

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Other records listing Ventlab Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120118VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERK102674CUFF SENTRYK093617VENTLAB 6000 SERIES HUMIDIFIERK093525ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHEK090840VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.K082204SERIES SY DISPOSABLE ELECTROSURGICAL PAD

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Related Devices (Code: BTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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