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FDA 510(k)

THE HAYEK OSCILLATOR

K-Number: K903745 · 1990-11-09

ApplicantFlexco Medical Instruments
Decision Date1990-11-09
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE HAYEK OSCILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Flexco Medical Instruments. It received FDA 510(k) clearance on 1990-11-09 under 510(k) number K903745. 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 THE HAYEK OSCILLATOR?

THE HAYEK OSCILLATOR is a medical device that received FDA 510(k) clearance on 1990-11-09. The listed applicant is Flexco Medical Instruments. The 510(k) number is K903745.

When did THE HAYEK OSCILLATOR receive FDA 510(k) clearance?

THE HAYEK OSCILLATOR received FDA 510(k) clearance on 1990-11-09, under 510(k) number K903745.

Who is the listed applicant for THE HAYEK OSCILLATOR?

The FDA 510(k) record lists Flexco Medical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE HAYEK OSCILLATOR?

The FDA product code for THE HAYEK OSCILLATOR 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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