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FDA 510(k)

NEV-10 NEGATIVE PRESSURE VENTILATOR

K-Number: K910947 · 1991-06-03

ApplicantLifecare Services, Inc.
Decision Date1991-06-03
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEV-10 NEGATIVE PRESSURE VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Lifecare Services, Inc.. It received FDA 510(k) clearance on 1991-06-03 under 510(k) number K910947. 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 NEV-10 NEGATIVE PRESSURE VENTILATOR?

NEV-10 NEGATIVE PRESSURE VENTILATOR is a medical device that received FDA 510(k) clearance on 1991-06-03. The listed applicant is Lifecare Services, Inc.. The 510(k) number is K910947.

When did NEV-10 NEGATIVE PRESSURE VENTILATOR receive FDA 510(k) clearance?

NEV-10 NEGATIVE PRESSURE VENTILATOR received FDA 510(k) clearance on 1991-06-03, under 510(k) number K910947.

Who is the listed applicant for NEV-10 NEGATIVE PRESSURE VENTILATOR?

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

What is the FDA product code for NEV-10 NEGATIVE PRESSURE VENTILATOR?

The FDA product code for NEV-10 NEGATIVE PRESSURE VENTILATOR is BYT.

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Other records listing Lifecare Services, 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.

K913423LIFECARE REMOTE ALARM IIK912224LIFECARE CPAP-100K894779LIFECARE NASAL MASK KIT CAT. NO. 06-800K895592FREEWAY NEBULIZER COMPRESSORK894361LIFECARE PRESSURE ALARM CAT. NO. 34-010K880378LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001

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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.K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.K903745THE HAYEK OSCILLATORFlexco Medical Instruments

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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