PHYSIOGLOVE ET SYSTEM— 510(k) K133703

Substantially Equivalent

Commwell R&D , Ltd.

FDA 510(k) clearance K133703 for PHYSIOGLOVE ET SYSTEM, Substantially Equivalent on 2014-08-18. Applicant: Commwell R&D , Ltd.. Device class: 2.

Clearance details

Applicant
Commwell R&D , Ltd.
Product code
Code DXH
Device class
Class 2
Regulation
21 CFR 870.2920
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
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