The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Audicor Sensor-adapter Model Audicor Sensor-adapter 4.0.
| Device ID | K103516 |
| 510k Number | K103516 |
| Device Name: | AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 |
| Classification | Stethoscope, Electronic |
| 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 | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-30 |
| Decision Date | 2011-02-04 |
| Summary: | summary |