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FDA 510(k)

HAYEK OSCILLATOR, MODIFICATION

K-Number: K921726 · 1992-04-23

ApplicantRespironics, Inc.
Decision Date1992-04-23
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAYEK OSCILLATOR, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1992-04-23 under 510(k) number K921726. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAYEK OSCILLATOR, MODIFICATION?

HAYEK OSCILLATOR, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-04-23. The listed applicant is Respironics, Inc.. The 510(k) number is K921726.

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

HAYEK OSCILLATOR, MODIFICATION received FDA 510(k) clearance on 1992-04-23, under 510(k) number K921726.

Who is the listed applicant for HAYEK OSCILLATOR, MODIFICATION?

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, MODIFICATION?

The FDA product code for HAYEK OSCILLATOR, MODIFICATION is CBK.

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Related Devices (Code: CBK)

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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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