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 |