The following data is part of a premarket notification filed by Northeast Monitoring, Inc. with the FDA for Northeast Monitoring Dr180.
| Device ID | K960925 |
| 510k Number | K960925 |
| Device Name: | NORTHEAST MONITORING DR180 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | NORTHEAST MONITORING, INC. 730 BOSTON POST RD., SUITE 22 Sudbury, MA 01776 |
| Contact | Mark Hubelbank |
| Correspondent | Mark Hubelbank NORTHEAST MONITORING, INC. 730 BOSTON POST RD., SUITE 22 Sudbury, MA 01776 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-06 |
| Decision Date | 1996-07-31 |