The following data is part of a premarket notification filed by Prodol Meditec Ltd. with the FDA for Airtraq Sp Airtraq Avant.
| Device ID | K121378 |
| 510k Number | K121378 |
| Device Name: | AIRTRAQ SP AIRTRAQ AVANT |
| Classification | Laryngoscope, Rigid |
| Applicant | PRODOL MEDITEC LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PRODOL MEDITEC LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-08 |
| Decision Date | 2012-06-21 |
| Summary: | summary |