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FDA 510(k)

FLYNN SERIES III BAG/MASK UNIT-

K-Number: K832495 · 1983-09-29

ApplicantO-Two Systems Intl., Inc.
Decision Date1983-09-29
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLYNN SERIES III BAG/MASK UNIT- is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Systems Intl., Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832495. 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 FLYNN SERIES III BAG/MASK UNIT-?

FLYNN SERIES III BAG/MASK UNIT- is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is O-Two Systems Intl., Inc.. The 510(k) number is K832495.

When did FLYNN SERIES III BAG/MASK UNIT- receive FDA 510(k) clearance?

FLYNN SERIES III BAG/MASK UNIT- received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832495.

Who is the listed applicant for FLYNN SERIES III BAG/MASK UNIT-?

The FDA 510(k) record lists O-Two Systems Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLYNN SERIES III BAG/MASK UNIT-?

The FDA product code for FLYNN SERIES III BAG/MASK UNIT- is BTM.

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Other records listing O-Two Systems Intl., 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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