The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Audicor Upgrade System.
| Device ID | K032145 |
| 510k Number | K032145 |
| Device Name: | AUDICOR UPGRADE SYSTEM |
| Classification | Electrocardiograph |
| Applicant | INOVISE MEDICAL, INC. 1025 INDUSTRIAL PKWY. SUITE C Newberg, OR 97132 |
| Contact | Steve Hesler |
| Correspondent | Steve Hesler INOVISE MEDICAL, INC. 1025 INDUSTRIAL PKWY. SUITE C Newberg, OR 97132 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-14 |
| Decision Date | 2003-10-31 |
| Summary: | summary |