The following data is part of a premarket notification filed by Cybermedic, Inc. with the FDA for Model 1010, Cy-met.
| Device ID | K884910 |
| 510k Number | K884910 |
| Device Name: | MODEL 1010, CY-MET |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | CYBERMEDIC, INC. 740 SO PIERCE AVE. P.O. BOX 700 Louisville, CO 80027 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward CYBERMEDIC, INC. 740 SO PIERCE AVE. P.O. BOX 700 Louisville, CO 80027 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-25 |
| Decision Date | 1989-06-12 |