The following data is part of a premarket notification filed by Northeast Monitoring, Inc. with the FDA for Telaheart Digital Recorder.
| Device ID | K061293 |
| 510k Number | K061293 |
| Device Name: | TELAHEART DIGITAL RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | NORTHEAST MONITORING, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary NORTHEAST MONITORING, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-09 |
| Decision Date | 2006-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M581NEMK960 | K061293 | 000 |
| M581NEMK950 | K061293 | 000 |
| M581NEMK940 | K061293 | 000 |
| M581NEMK1950 | K061293 | 000 |
| M581NEMK1290 | K061293 | 000 |