The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for A/t X-ray 70.
Device ID | K024285 |
510k Number | K024285 |
Device Name: | A/T X-RAY 70 |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11801 |
Contact | Joseph Carey |
Correspondent | Joseph Carey AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11801 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-23 |
Decision Date | 2003-04-16 |