FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFUSION MONITOR
K Number: K900860
·
Decision Aug 14, 1990
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
4
Review Days
172
Basic Information
- Device Name
- PERFUSION MONITOR
- K Number
- K900860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4410
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CARDIO METRICS, INC.
- Date Received
- February 23, 1990
- Decision Date
- August 14, 1990
- Product Code
- DTY
- 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 |
|---|---|---|---|
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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