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FDA 510(k)

VENTILATOR EXTERNAL BODY NEGATIVE PRESS

K-Number: K841090 · 1984-05-30

ApplicantPorta-Lung Co.
Decision Date1984-05-30
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTILATOR EXTERNAL BODY NEGATIVE PRESS is the device name listed in this FDA 510(k) record. The listed applicant is Porta-Lung Co.. It received FDA 510(k) clearance on 1984-05-30 under 510(k) number K841090. The device is classified under product code BYT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTILATOR EXTERNAL BODY NEGATIVE PRESS?

VENTILATOR EXTERNAL BODY NEGATIVE PRESS is a medical device that received FDA 510(k) clearance on 1984-05-30. The listed applicant is Porta-Lung Co.. The 510(k) number is K841090.

When did VENTILATOR EXTERNAL BODY NEGATIVE PRESS receive FDA 510(k) clearance?

VENTILATOR EXTERNAL BODY NEGATIVE PRESS received FDA 510(k) clearance on 1984-05-30, under 510(k) number K841090.

Who is the listed applicant for VENTILATOR EXTERNAL BODY NEGATIVE PRESS?

The FDA 510(k) record lists Porta-Lung Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTILATOR EXTERNAL BODY NEGATIVE PRESS?

The FDA product code for VENTILATOR EXTERNAL BODY NEGATIVE PRESS is BYT.

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Related Devices (Code: BYT)

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.

K082657RTX RESPIRATORMedivent LimitedK072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia SrlK924341HAYEK OSCILLATOR(TM)Respironics, Inc.K910947NEV-10 NEGATIVE PRESSURE VENTILATORLifecare Services, Inc.K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.

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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