The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Audicor Cpam With Sdb (cardiopulmonary Ambulatory Monitor With Sleep Disordered Breathing Detection).
| Device ID | K120462 |
| 510k Number | K120462 |
| Device Name: | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | INOVISE MEDICAL, INC. 8770 SW NIMBUS AVE. SUITE D Beaverton, OR 97008 |
| Contact | Earl Anderson |
| Correspondent | Earl Anderson INOVISE MEDICAL, INC. 8770 SW NIMBUS AVE. SUITE D Beaverton, OR 97008 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-15 |
| Decision Date | 2012-09-20 |
| Summary: | summary |