FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM FLOW COUPLER Monitor (GEM1020M-2)
K Number: K213974
·
Decision Apr 20, 2022
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
134
Applicant Total
2
Review Days
121
Basic Information
- Device Name
- GEM FLOW COUPLER Monitor (GEM1020M-2)
- K Number
- K213974
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synovis Micro Companies Alliance, Inc.
- Date Received
- December 20, 2021
- Decision Date
- April 20, 2022
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
| K221843 | GEM Biover Microvascular Clamps | Sep 14, 2022 | Substantially Equivalent |