ivWatch— 510(k) K162478

Substantially Equivalent

Ivwatch, LLC

FDA 510(k) clearance K162478 for ivWatch, Substantially Equivalent on 2016-12-22. Applicant: Ivwatch, LLC.

Clearance details

Applicant: Ivwatch, LLC
Product code: Code PMS
Advisory panel: General Hospital
Date received: 2016-09-06
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, VA, US

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