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FDA 510(k)

MYOVISION 3.0 WIREFREE SYSTEM

K-Number: K123399 · 2013-08-01

ApplicantPrecision Biometrics, Inc.
Decision Date2013-08-01
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MYOVISION 3.0 WIREFREE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biometrics, Inc.. It received FDA 510(k) clearance on 2013-08-01 under 510(k) number K123399. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOVISION 3.0 WIREFREE SYSTEM?

MYOVISION 3.0 WIREFREE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-01. The listed applicant is Precision Biometrics, Inc.. The 510(k) number is K123399.

When did MYOVISION 3.0 WIREFREE SYSTEM receive FDA 510(k) clearance?

MYOVISION 3.0 WIREFREE SYSTEM received FDA 510(k) clearance on 2013-08-01, under 510(k) number K123399.

Who is the listed applicant for MYOVISION 3.0 WIREFREE SYSTEM?

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

What is the FDA product code for MYOVISION 3.0 WIREFREE SYSTEM?

The FDA product code for MYOVISION 3.0 WIREFREE SYSTEM is IKN.

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Related Devices (Code: IKN)

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.

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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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