The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Audicor Cpam With Sdb (single Sensor).
| Device ID | K130660 |
| 510k Number | K130660 |
| Device Name: | AUDICOR CPAM WITH SDB (SINGLE SENSOR) |
| 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 | 2013-03-12 |
| Decision Date | 2013-10-11 |
| Summary: | summary |