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FDA 510(k)

MYOSURE CONTROL UNIT

K-Number: K120593 · 2012-03-23

ApplicantHologic, Inc.
Decision Date2012-03-23
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MYOSURE CONTROL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2012-03-23 under 510(k) number K120593. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOSURE CONTROL UNIT?

MYOSURE CONTROL UNIT is a medical device that received FDA 510(k) clearance on 2012-03-23. The listed applicant is Hologic, Inc.. The 510(k) number is K120593.

When did MYOSURE CONTROL UNIT receive FDA 510(k) clearance?

MYOSURE CONTROL UNIT received FDA 510(k) clearance on 2012-03-23, under 510(k) number K120593.

Who is the listed applicant for MYOSURE CONTROL UNIT?

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

What is the FDA product code for MYOSURE CONTROL UNIT?

The FDA product code for MYOSURE CONTROL UNIT is HIH.

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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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