Phoenix— 510(k) K183152

Substantially Equivalent

Us Bionics, Inc. (Dba Suitx)

FDA 510(k) clearance K183152 for Phoenix, Substantially Equivalent on 2019-04-17. Applicant: Us Bionics, Inc. (Dba Suitx). Device class: 2.

Clearance details

Applicant
Us Bionics, Inc. (Dba Suitx)
Product code
Code PHL
Device class
Class 2
Regulation
21 CFR 890.3480
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Emeryville, CA, US
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