The following data is part of a premarket notification filed by Paceart, Inc. with the FDA for Paceart Cardiovoice.
| Device ID | K952065 |
| 510k Number | K952065 |
| Device Name: | PACEART CARDIOVOICE |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | PACEART, INC. 22 RIVERVIEW DR. Wayne, NJ 07470 |
| Contact | Michael N Bergelson |
| Correspondent | Michael N Bergelson PACEART, INC. 22 RIVERVIEW DR. Wayne, NJ 07470 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-02 |
| Decision Date | 1996-01-16 |