FDA 510(k)

MHS 5000

K-Number: K011981 · 2001-09-05

Decision Date2001-09-05

Product CodeLHQ

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

MHS 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Micro Health Systems, Inc.. It received FDA 510(k) clearance on 2001-09-05 under 510(k) number K011981. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MHS 5000?

MHS 5000 is a medical device that received FDA 510(k) clearance on 2001-09-05. The listed applicant is Micro Health Systems, Inc.. The 510(k) number is K011981.

When did MHS 5000 receive FDA 510(k) clearance?

MHS 5000 received FDA 510(k) clearance on 2001-09-05, under 510(k) number K011981.

Who is the listed applicant for MHS 5000?

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

What is the FDA product code for MHS 5000?

The FDA product code for MHS 5000 is LHQ.

Other records listing Micro Health Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030018MHS 7000 K021956MHS MED LIGHT 1000

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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.