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FDA 510(k)

VASCULAB #VSC21

K-Number: K812609 · 1981-10-02

ApplicantMedasonics, Inc.
Decision Date1981-10-02
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAB #VSC21 is the device name listed in this FDA 510(k) record. The listed applicant is Medasonics, Inc.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812609. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAB #VSC21?

VASCULAB #VSC21 is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Medasonics, Inc.. The 510(k) number is K812609.

When did VASCULAB #VSC21 receive FDA 510(k) clearance?

VASCULAB #VSC21 received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812609.

Who is the listed applicant for VASCULAB #VSC21?

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

What is the FDA product code for VASCULAB #VSC21?

The FDA product code for VASCULAB #VSC21 is JOM.

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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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