GEM FLOW COUPLER Monitor (GEM1020M-2)— 510(k) K213974
Substantially EquivalentSynovis Micro Companies Alliance, Inc.
FDA 510(k) clearance K213974 for GEM FLOW COUPLER Monitor (GEM1020M-2), Substantially Equivalent on 2022-04-20. Applicant: Synovis Micro Companies Alliance, Inc.. Device class: 2.
Clearance details
- Applicant
- Synovis Micro Companies Alliance, Inc.
- Product code
- Code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Birmingham, AL, US
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