The following data is part of a premarket notification filed by Northeast Monitoring, Inc. with the FDA for Sd360 Digital Recorder/sd360 Holter Digital Recorder.
| Device ID | K041901 |
| 510k Number | K041901 |
| Device Name: | SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | NORTHEAST MONITORING, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph 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 | 2004-07-14 |
| Decision Date | 2004-08-31 |
| Summary: | summary |