The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Model 1010 Physiological Signal Telemetry Monitor.
| Device ID | K873672 |
| 510k Number | K873672 |
| Device Name: | MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | Robert E Yocher |
| Correspondent | Robert E Yocher NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-11 |
| Decision Date | 1987-12-03 |