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 |