The following data is part of a premarket notification filed by Paceart, Inc. with the FDA for Paceart Cpts-86/12.
| Device ID | K915632 |
| 510k Number | K915632 |
| Device Name: | PACEART CPTS-86/12 |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| Applicant | PACEART, INC. 22 RIVERVIEW DR. Wayne, NJ 07470 |
| Contact | Michael Bergelson |
| Correspondent | Michael Bergelson PACEART, INC. 22 RIVERVIEW DR. Wayne, NJ 07470 |
| Product Code | KRE |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-17 |
| Decision Date | 1992-04-14 |