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FDA 510(k)

OHMEDA INFANT RESUSCITATION SYSTEM

K-Number: K971243 · 1997-12-02

ApplicantOhmeda Medical
Decision Date1997-12-02
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OHMEDA INFANT RESUSCITATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1997-12-02 under 510(k) number K971243. 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 OHMEDA INFANT RESUSCITATION SYSTEM?

OHMEDA INFANT RESUSCITATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-02. The listed applicant is Ohmeda Medical. The 510(k) number is K971243.

When did OHMEDA INFANT RESUSCITATION SYSTEM receive FDA 510(k) clearance?

OHMEDA INFANT RESUSCITATION SYSTEM received FDA 510(k) clearance on 1997-12-02, under 510(k) number K971243.

Who is the listed applicant for OHMEDA INFANT RESUSCITATION SYSTEM?

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

What is the FDA product code for OHMEDA INFANT RESUSCITATION SYSTEM?

The FDA product code for OHMEDA INFANT RESUSCITATION SYSTEM is BTM.

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Other records listing Ohmeda Medical 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.

K123309GIRAFFE AND PANDA WARMERSK101788GIRAFFE OMNIBEDK101778GIRAFFE INCUBATORK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070377GIRAFFE AND PANDA WARMER

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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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