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FDA 510(k)

SONOCALC

K-Number: K030223 · 2003-02-06

ApplicantSonometric Health, LLC
Decision Date2003-02-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOCALC is the device name listed in this FDA 510(k) record. The listed applicant is Sonometric Health, LLC. It received FDA 510(k) clearance on 2003-02-06 under 510(k) number K030223. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOCALC?

SONOCALC is a medical device that received FDA 510(k) clearance on 2003-02-06. The listed applicant is Sonometric Health, LLC. The 510(k) number is K030223.

When did SONOCALC receive FDA 510(k) clearance?

SONOCALC received FDA 510(k) clearance on 2003-02-06, under 510(k) number K030223.

Who is the listed applicant for SONOCALC?

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

What is the FDA product code for SONOCALC?

The FDA product code for SONOCALC is LLZ.

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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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