The following data is part of a premarket notification filed by Bicore Monitoring Systems with the FDA for Biore Cp-100 Cardiopulmonary Monitor.
| Device ID | K900696 |
| 510k Number | K900696 |
| Device Name: | BIORE CP-100 CARDIOPULMONARY MONITOR |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | BICORE MONITORING SYSTEMS 2 FARADAY Irvine, CA 92718 |
| Contact | David B Viele |
| Correspondent | David B Viele BICORE MONITORING SYSTEMS 2 FARADAY Irvine, CA 92718 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-11-29 |