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FDA 510(k)

MANUAL RESUSCITATOR WITH ACE

K-Number: K982215 · 1998-09-18

ApplicantMedical Marketing Concepts
Decision Date1998-09-18
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MANUAL RESUSCITATOR WITH ACE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Marketing Concepts. It received FDA 510(k) clearance on 1998-09-18 under 510(k) number K982215. 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 MANUAL RESUSCITATOR WITH ACE?

MANUAL RESUSCITATOR WITH ACE is a medical device that received FDA 510(k) clearance on 1998-09-18. The listed applicant is Medical Marketing Concepts. The 510(k) number is K982215.

When did MANUAL RESUSCITATOR WITH ACE receive FDA 510(k) clearance?

MANUAL RESUSCITATOR WITH ACE received FDA 510(k) clearance on 1998-09-18, under 510(k) number K982215.

Who is the listed applicant for MANUAL RESUSCITATOR WITH ACE?

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

What is the FDA product code for MANUAL RESUSCITATOR WITH ACE?

The FDA product code for MANUAL RESUSCITATOR WITH ACE is BTM.

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Other records listing Medical Marketing Concepts as applicant

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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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