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FDA 510(k)

MYO-METRIC II

K-Number: K811312 · 1981-06-09

ApplicantMycron Medical, Inc.
Decision Date1981-06-09
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MYO-METRIC II is the device name listed in this FDA 510(k) record. The listed applicant is Mycron Medical, Inc.. It received FDA 510(k) clearance on 1981-06-09 under 510(k) number K811312. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYO-METRIC II?

MYO-METRIC II is a medical device that received FDA 510(k) clearance on 1981-06-09. The listed applicant is Mycron Medical, Inc.. The 510(k) number is K811312.

When did MYO-METRIC II receive FDA 510(k) clearance?

MYO-METRIC II received FDA 510(k) clearance on 1981-06-09, under 510(k) number K811312.

Who is the listed applicant for MYO-METRIC II?

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

What is the FDA product code for MYO-METRIC II?

The FDA product code for MYO-METRIC II is LBB.

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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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