ivWatch Model 400— 510(k) K142374

Substantially Equivalent

Ivwatch, LLC

FDA 510(k) clearance K142374 for ivWatch Model 400, Substantially Equivalent on 2015-02-13. Applicant: Ivwatch, LLC.

Clearance details

Applicant: Ivwatch, LLC
Product code: Code MRZ
Advisory panel: General Hospital
Date received: 2014-08-26
Decision date: 2015-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

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