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FDA 510(k)

OMNICORDER, MODEL 464

K-Number: K990027 · 1999-02-09

ApplicantDel Mar Avionics
Decision Date1999-02-09
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNICORDER, MODEL 464 is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1999-02-09 under 510(k) number K990027. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNICORDER, MODEL 464?

OMNICORDER, MODEL 464 is a medical device that received FDA 510(k) clearance on 1999-02-09. The listed applicant is Del Mar Avionics. The 510(k) number is K990027.

When did OMNICORDER, MODEL 464 receive FDA 510(k) clearance?

OMNICORDER, MODEL 464 received FDA 510(k) clearance on 1999-02-09, under 510(k) number K990027.

Who is the listed applicant for OMNICORDER, MODEL 464?

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

What is the FDA product code for OMNICORDER, MODEL 464?

The FDA product code for OMNICORDER, MODEL 464 is DSH.

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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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