The following data is part of a premarket notification filed by Paceart, Inc. with the FDA for Paceart Home Trak Plus Easi Event Recorder System.
| Device ID | K982090 |
| 510k Number | K982090 |
| Device Name: | PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | PACEART, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers PACEART, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-15 |
| Decision Date | 1999-01-26 |
| Summary: | summary |