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FDA 510(k)

SONOMARK

K-Number: K061560 · 2006-08-18

ApplicantMedical Products Manufacturing, Inc.
Decision Date2006-08-18
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOMARK is the device name listed in this FDA 510(k) record. The listed applicant is Medical Products Manufacturing, Inc.. It received FDA 510(k) clearance on 2006-08-18 under 510(k) number K061560. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOMARK?

SONOMARK is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is Medical Products Manufacturing, Inc.. The 510(k) number is K061560.

When did SONOMARK receive FDA 510(k) clearance?

SONOMARK received FDA 510(k) clearance on 2006-08-18, under 510(k) number K061560.

Who is the listed applicant for SONOMARK?

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

What is the FDA product code for SONOMARK?

The FDA product code for SONOMARK is ITX.

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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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