The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Pulse Oximeter, Model 500.
| Device ID | K853124 |
| 510k Number | K853124 |
| Device Name: | NOVAMETRIX PULSE OXIMETER, MODEL 500 |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | Paul U Buday |
| Correspondent | Paul U Buday NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-25 |
| Decision Date | 1985-11-06 |