The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Airway Thermistor.
| Device ID | K914219 |
| 510k Number | K914219 |
| Device Name: | AIRWAY THERMISTOR |
| Classification | Spirometer, Diagnostic |
| Applicant | SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
| Contact | Anna Pettersson |
| Correspondent | Anna Pettersson SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-19 |
| Decision Date | 1992-02-26 |