ivWatch Model 400— 510(k) K153605

Substantially Equivalent

Ivwatch, LLC

FDA 510(k) clearance K153605 for ivWatch Model 400, Substantially Equivalent on 2016-02-11. Applicant: Ivwatch, LLC.

Clearance details

Applicant: Ivwatch, LLC
Product code: Code PMS
Advisory panel: General Hospital
Date received: 2015-12-17
Decision date: 2016-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Williamsburg, VA, US

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