The following data is part of a premarket notification filed by Northeast Monitoring, Inc. with the FDA for Dr180-ii.
| Device ID | K001288 |
| 510k Number | K001288 |
| Device Name: | DR180-II |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | NORTHEAST MONITORING, INC. 730 BOSTON POST RD. SUITE 23 Sudbury, MA 01776 |
| Contact | Rodney L Cambre |
| Correspondent | Rodney L Cambre NORTHEAST MONITORING, INC. 730 BOSTON POST RD. SUITE 23 Sudbury, MA 01776 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-24 |
| Decision Date | 2000-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M581NEMK1400 | K001288 | 000 |
| M581NEMK1390 | K001288 | 000 |
| M581NEMK1380 | K001288 | 000 |