ivWatch Model 400— 510(k) K222212

Substantially Equivalent

Ivwatch, LLC

FDA 510(k) clearance K222212 for ivWatch Model 400, Substantially Equivalent on 2022-08-24. Applicant: Ivwatch, LLC.

Clearance details

Applicant: Ivwatch, LLC
Product code: Code PMS
Advisory panel: General Hospital
Date received: 2022-07-25
Decision date: 2022-08-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Newport News, VA, US

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