The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Audicor 200 System, Models 200d And 200s.
| Device ID | K070136 |
| 510k Number | K070136 |
| Device Name: | AUDICOR 200 SYSTEM, MODELS 200D AND 200S |
| Classification | Electrocardiograph |
| Applicant | INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 Portland, OR 97223 |
| Contact | Steve Hesler |
| Correspondent | Steve Hesler INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 Portland, OR 97223 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-04-13 |
| Summary: | summary |