The following data is part of a premarket notification filed by Northeast Monitoring, Inc. with the FDA for Dr180-r/oxy.
| Device ID | K983576 |
| 510k Number | K983576 |
| Device Name: | DR180-R/OXY |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | NORTHEAST MONITORING, INC. 730 BOSTON POST RD., SUITE 22 Sudbury, MA 01776 |
| Contact | Rodney L Cambre |
| Correspondent | Rodney L Cambre NORTHEAST MONITORING, INC. 730 BOSTON POST RD., SUITE 22 Sudbury, MA 01776 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1999-03-23 |
| Summary: | summary |