The following data is part of a premarket notification filed by Paceart, Inc. with the FDA for Paceart Wrist Electrodes.
| Device ID | K960721 |
| 510k Number | K960721 |
| Device Name: | PACEART WRIST ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | PACEART, INC. 22 RIVERVIEW DR. Wayne, NJ 07470 |
| Contact | Michael Bergleson, Ph.d. |
| Correspondent | Michael Bergleson, Ph.d. PACEART, INC. 22 RIVERVIEW DR. Wayne, NJ 07470 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-22 |
| Decision Date | 1996-07-18 |
| Summary: | summary |