The following data is part of a premarket notification filed by Bicore Monitoring Systems with the FDA for Bicore Smartvalve Occlusion Valve.
| Device ID | K921717 |
| 510k Number | K921717 |
| Device Name: | BICORE SMARTVALVE OCCLUSION VALVE |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | BICORE MONITORING SYSTEMS 2 FARADAY Irvine, CA 92718 |
| Contact | Muir S Meinhold |
| Correspondent | Muir S Meinhold BICORE MONITORING SYSTEMS 2 FARADAY Irvine, CA 92718 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-09 |
| Decision Date | 1992-11-06 |