The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novatracer Recorder.
| Device ID | K811453 |
| 510k Number | K811453 |
| Device Name: | NOVATRACER RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-22 |
| Decision Date | 1981-07-10 |