The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Tidal Wave Carbon Dioxide Monitor, Model 610.
| Device ID | K963327 |
| 510k Number | K963327 |
| Device Name: | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | Robert H Schiffman |
| Correspondent | Robert H Schiffman NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-23 |
| Decision Date | 1996-11-20 |