The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Audicor Sensor, Models: 2.0, 3.0.
| Device ID | K080602 |
| 510k Number | K080602 |
| Device Name: | AUDICOR SENSOR, MODELS: 2.0, 3.0 |
| Classification | Electrode, Electrocardiograph |
| Applicant | INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 Portland, OR 97223 |
| Contact | Kendra Rathkey |
| Correspondent | Kendra Rathkey INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 Portland, OR 97223 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-09-25 |
| Summary: | summary |