PlasmaWave— 510(k) K211253

Substantially Equivalent

Manamed, Inc.

FDA 510(k) clearance K211253 for PlasmaWave, Substantially Equivalent on 2021-05-26. Applicant: Manamed, Inc.. Device class: 2.

Clearance details

Applicant
Manamed, Inc.
Product code
Code JOW
Device class
Class 2
Regulation
21 CFR 870.5800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Las Vegas, NV, US
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