The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Audicor Cpam With Sdb (accelerometer Based).
| Device ID | K131883 |
| 510k Number | K131883 |
| Device Name: | AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) |
| Classification | Ventilatory Effort Recorder |
| Applicant | INOVISE MEDICAL, INC. 8770 SW NIMBUS AVENUE SUITE D Beaverton, OR 97008 -7196 |
| Contact | Earl Anderson |
| Correspondent | Earl Anderson INOVISE MEDICAL, INC. 8770 SW NIMBUS AVENUE SUITE D Beaverton, OR 97008 -7196 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2014-04-11 |
| Summary: | summary |