MYOVISION 3.0 WIREFREE SYSTEM— 510(k) K123399

Name: FDA 510(k) clearance K123399
Creator: U.S. Food and Drug Administration
Published: 2013-08-01

Substantially Equivalent

Precision Biometrics, Inc.

FDA 510(k) clearance K123399 for MYOVISION 3.0 WIREFREE SYSTEM, Substantially Equivalent on 2013-08-01. Applicant: Precision Biometrics, Inc.. Device class: 2.

Clearance details

Applicant: Precision Biometrics, Inc.
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2012-11-05
Decision date: 2013-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.