The following data is part of a premarket notification filed by North East Monitoring Inc. with the FDA for Dr300 Holter Monitor.
| Device ID | K142424 |
| 510k Number | K142424 |
| Device Name: | DR300 HOLTER MONITOR |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | NORTH EAST MONITORING INC. 2 CLOCK TOWER PLACE, STE 555 Maynard, MA 01754 |
| Contact | Sherry Steele |
| Correspondent | Sherry Steele NORTH EAST MONITORING INC. 2 CLOCK TOWER PLACE, STE 555 Maynard, MA 01754 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-29 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M581NEMK1570 | K142424 | 000 |
| M581NEMK1560 | K142424 | 000 |
| M581NEMK1550 | K142424 | 000 |
| M581NEMK1540 | K142424 | 000 |