The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Cardiovise Ecg Interpretative Software.
| Device ID | K001349 |
| 510k Number | K001349 |
| Device Name: | CARDIOVISE ECG INTERPRETATIVE SOFTWARE |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | INOVISE MEDICAL, INC. 1025 INDUSTRIAL PKWY. SUITE C Newberg, OR 97132 |
| Contact | Debra A Olson |
| Correspondent | Debra A Olson INOVISE MEDICAL, INC. 1025 INDUSTRIAL PKWY. SUITE C Newberg, OR 97132 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-28 |
| Decision Date | 2000-07-27 |