510(k) K900696
K900696 is an FDA 510(k) premarket notification submitted by Bicore Monitoring Systems for the device "BIORE CP-100 CARDIOPULMONARY MONITOR". The FDA issued a decision of Substantially Equivalent on November 29, 1990. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Bicore Monitoring Systems has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1990
- Date Received
- February 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Data
- Device Class
- Class II
- Regulation Number
- 868.1880
- Review Panel
- AN
- Submission Type