ACCENT

System, X-ray, Extraoral Source, Digital

AIR TECHNIQUES, INC.

The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Accent.

Pre-market Notification Details

• Device ID: K050693
• 510k Number: K050693
• Device Name: ACCENT
• Classification: System, X-ray, Extraoral Source, Digital
• 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: MUH
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-17
• Decision Date: 2005-05-26