The following data is part of a premarket notification filed by Arvee Medical, Inc. with the FDA for Arvee Apnea Monitor, Model 4800.
| Device ID | K900730 |
| 510k Number | K900730 |
| Device Name: | ARVEE APNEA MONITOR, MODEL 4800 |
| Classification | Monitor, Breathing Frequency |
| Applicant | ARVEE MEDICAL, INC. 730 E. MICHIGAN AVE. Battle Creek, MI 49016 |
| Contact | Kumar Kulkarni |
| Correspondent | Kumar Kulkarni ARVEE MEDICAL, INC. 730 E. MICHIGAN AVE. Battle Creek, MI 49016 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-15 |
| Decision Date | 1990-06-14 |