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FDA 510(k)

SONACARE SOUND MASSAGER

K-Number: K921000 · 1993-03-31

ApplicantHonor Trading, Ltd.
Decision Date1993-03-31
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SONACARE SOUND MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Honor Trading, Ltd.. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K921000. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONACARE SOUND MASSAGER?

SONACARE SOUND MASSAGER is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Honor Trading, Ltd.. The 510(k) number is K921000.

When did SONACARE SOUND MASSAGER receive FDA 510(k) clearance?

SONACARE SOUND MASSAGER received FDA 510(k) clearance on 1993-03-31, under 510(k) number K921000.

Who is the listed applicant for SONACARE SOUND MASSAGER?

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

What is the FDA product code for SONACARE SOUND MASSAGER?

The FDA product code for SONACARE SOUND MASSAGER is ISA.

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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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