The following data is part of a premarket notification filed by Paceart, Inc. with the FDA for Paceart Tx3 Cardiac Event Recorder.
| Device ID | K012407 |
| 510k Number | K012407 |
| Device Name: | PACEART TX3 CARDIAC EVENT RECORDER |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-30 |
| Decision Date | 2001-08-14 |
| Summary: | summary |