The following data is part of a premarket notification filed by Paceart, Inc. with the FDA for Pacemaker Function Analyzer.
| Device ID | K870909 |
| 510k Number | K870909 |
| Device Name: | PACEMAKER FUNCTION ANALYZER |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| Applicant | PACEART, INC. 159 MILLBURN AVE. Millburn, NJ 07041 |
| Contact | Michael Bergelson |
| Correspondent | Michael Bergelson PACEART, INC. 159 MILLBURN AVE. Millburn, NJ 07041 |
| Product Code | KRE |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-05 |
| Decision Date | 1987-04-27 |