The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Audicor Ca300/cc100 Analyzer With Sdb.
| Device ID | K151433 |
| 510k Number | K151433 |
| Device Name: | AUDICOR CA300/CC100 Analyzer With SDB |
| Classification | Ventilatory Effort Recorder |
| Applicant | INOVISE MEDICAL, INC. 8770 SW NIMBUS AVENUE SUITE D Beaverton, OR 97008 |
| Contact | Earl Anderson |
| Correspondent | Earl Anderson INOVISE MEDICAL, INC. 8770 SW NIMBUS AVENUE SUITE D Beaverton, OR 97008 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-28 |
| Decision Date | 2016-03-18 |
| Summary: | summary |