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FDA 510(k)

INFANT STAR SERIES 500

K-Number: K923704 · 1992-10-22

ApplicantInfrasonics Corp.
Decision Date1992-10-22
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT STAR SERIES 500 is the device name listed in this FDA 510(k) record. The listed applicant is Infrasonics Corp.. It received FDA 510(k) clearance on 1992-10-22 under 510(k) number K923704. 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 INFANT STAR SERIES 500?

INFANT STAR SERIES 500 is a medical device that received FDA 510(k) clearance on 1992-10-22. The listed applicant is Infrasonics Corp.. The 510(k) number is K923704.

When did INFANT STAR SERIES 500 receive FDA 510(k) clearance?

INFANT STAR SERIES 500 received FDA 510(k) clearance on 1992-10-22, under 510(k) number K923704.

Who is the listed applicant for INFANT STAR SERIES 500?

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

What is the FDA product code for INFANT STAR SERIES 500?

The FDA product code for INFANT STAR SERIES 500 is CBK.

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Other records listing Infrasonics Corp. as applicant

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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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