The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix 350 Recorder-paper Chart Recorder.
| Device ID | K850487 |
| 510k Number | K850487 |
| Device Name: | NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | Paul V Budax |
| Correspondent | Paul V Budax NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-07 |
| Decision Date | 1985-03-29 |