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FDA 510(k)

HAYEK OSCILLATOR(TM)

K-Number: K924341 · 1993-07-21

ApplicantRespironics, Inc.
Decision Date1993-07-21
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAYEK OSCILLATOR(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1993-07-21 under 510(k) number K924341. 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 HAYEK OSCILLATOR(TM)?

HAYEK OSCILLATOR(TM) is a medical device that received FDA 510(k) clearance on 1993-07-21. The listed applicant is Respironics, Inc.. The 510(k) number is K924341.

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

HAYEK OSCILLATOR(TM) received FDA 510(k) clearance on 1993-07-21, under 510(k) number K924341.

Who is the listed applicant for HAYEK OSCILLATOR(TM)?

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

What is the FDA product code for HAYEK OSCILLATOR(TM)?

The FDA product code for HAYEK OSCILLATOR(TM) 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.

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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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