FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIORE CP-100 CARDIOPULMONARY MONITOR
K Number: K900696
·
Decision Nov 29, 1990
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
4
Review Days
289
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Basic Information
- Device Name
- BIORE CP-100 CARDIOPULMONARY MONITOR
- K Number
- K900696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bicore Monitoring Systems
- Date Received
- February 13, 1990
- Decision Date
- November 29, 1990
- Product Code
- BZC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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