PlasmaFlow— 510(k) K160318
Substantially EquivalentManamed, Inc.
FDA 510(k) clearance K160318 for PlasmaFlow, Substantially Equivalent on 2016-04-01. 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
- Traditional
- Location
- Costa Mesa, CA, US
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