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FDA 510(k)

EMERGENCY OXYGEN RESUSCITATOR

K-Number: K771299 · 1977-08-04

ApplicantFraser Sweatman, Inc.
Decision Date1977-08-04
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMERGENCY OXYGEN RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Fraser Sweatman, Inc.. It received FDA 510(k) clearance on 1977-08-04 under 510(k) number K771299. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMERGENCY OXYGEN RESUSCITATOR?

EMERGENCY OXYGEN RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is Fraser Sweatman, Inc.. The 510(k) number is K771299.

When did EMERGENCY OXYGEN RESUSCITATOR receive FDA 510(k) clearance?

EMERGENCY OXYGEN RESUSCITATOR received FDA 510(k) clearance on 1977-08-04, under 510(k) number K771299.

Who is the listed applicant for EMERGENCY OXYGEN RESUSCITATOR?

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

What is the FDA product code for EMERGENCY OXYGEN RESUSCITATOR?

The FDA product code for EMERGENCY OXYGEN RESUSCITATOR is BTL.

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 Fraser Sweatman, 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.

K770911MEDISHIELD JORDON LIFTING FRAMEK770910MEDISHIELD CERVICAL COLLARK761140FRASER SWEATMAN'S DOUBLE MASKK760766PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXERK760076ABSORBER, ANESTHESIA CIRCLE SYS, CO2

Related Devices (Code: BTL)

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.

K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO KgaaK221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/AK202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KGK182956Puffin Lite Infant Resuscitation SystemInternational BiomedicalK173373SafeT T-Piece ResuscitatorVentlab, LLC

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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