FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM-CRIT CHECK
K Number: K871686
·
Decision Jun 18, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
46
Applicant Total
3
Review Days
50
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Basic Information
- Device Name
- GEM-CRIT CHECK
- K Number
- K871686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Diamond Sensor Systems
- Date Received
- April 29, 1987
- Decision Date
- June 18, 1987
- Product Code
- DRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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