The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Spirometer, Monitoring W/alarm.
| Device ID | K780064 |
| 510k Number | K780064 |
| Device Name: | SPIROMETER, MONITORING W/ALARM |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-12 |
| Decision Date | 1978-01-31 |