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FDA 510(k)

DATEX ENGSTOM MANUAL RESUSCITATOR

K-Number: K970991 · 1997-06-16

ApplicantPromedic, Inc.
Decision Date1997-06-16
Product CodeBTM
Advisory CommitteeAN
DecisionUnknown

Device Summary

DATEX ENGSTOM MANUAL RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Promedic, Inc.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K970991. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DATEX ENGSTOM MANUAL RESUSCITATOR?

DATEX ENGSTOM MANUAL RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Promedic, Inc.. The 510(k) number is K970991.

When did DATEX ENGSTOM MANUAL RESUSCITATOR receive FDA 510(k) clearance?

DATEX ENGSTOM MANUAL RESUSCITATOR received FDA 510(k) clearance on 1997-06-16, under 510(k) number K970991.

Who is the listed applicant for DATEX ENGSTOM MANUAL RESUSCITATOR?

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

What is the FDA product code for DATEX ENGSTOM MANUAL RESUSCITATOR?

The FDA product code for DATEX ENGSTOM MANUAL RESUSCITATOR is BTM.

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Other records listing Promedic, Inc. 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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