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FDA 510(k)

MyoStrain 5.1

K-Number: K182756 · 2019-02-14

ApplicantMyocardial Solutions
Decision Date2019-02-14
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MyoStrain 5.1 is a medical device manufactured by Myocardial Solutions. It received FDA 510(k) clearance on 2019-02-14 under approval number K182756. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyoStrain 5.1?

MyoStrain 5.1 is a medical device that received FDA 510(k) clearance on 2019-02-14. It is manufactured by Myocardial Solutions. The 510(k) number is K182756.

When was MyoStrain 5.1 approved by the FDA?

MyoStrain 5.1 received FDA 510(k) clearance on 2019-02-14, under approval number K182756.

What company makes MyoStrain 5.1?

MyoStrain 5.1 is manufactured by Myocardial Solutions.

What is the FDA product code for MyoStrain 5.1?

The FDA product code for MyoStrain 5.1 is LNH.

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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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