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FDA 510(k)

OPOMAT MANUAL RESUSCITATOR VENTILATOR

K-Number: K912620 · 1991-12-04

ApplicantEuro-Am Pharma, Inc.
Decision Date1991-12-04
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OPOMAT MANUAL RESUSCITATOR VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Euro-Am Pharma, Inc.. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K912620. 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 OPOMAT MANUAL RESUSCITATOR VENTILATOR?

OPOMAT MANUAL RESUSCITATOR VENTILATOR is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Euro-Am Pharma, Inc.. The 510(k) number is K912620.

When did OPOMAT MANUAL RESUSCITATOR VENTILATOR receive FDA 510(k) clearance?

OPOMAT MANUAL RESUSCITATOR VENTILATOR received FDA 510(k) clearance on 1991-12-04, under 510(k) number K912620.

Who is the listed applicant for OPOMAT MANUAL RESUSCITATOR VENTILATOR?

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

What is the FDA product code for OPOMAT MANUAL RESUSCITATOR VENTILATOR?

The FDA product code for OPOMAT MANUAL RESUSCITATOR VENTILATOR is BTM.

Related Clinical Trials

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.

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Other records listing Euro-Am Pharma, Inc. 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.

K900588ACU-BAND ACCUPRESSURE WRIST BAND

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

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

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