PLUS 1

System, Imaging, Pulsed Echo, Ultrasonic

DYMAX CORP.

The following data is part of a premarket notification filed by Dymax Corp. with the FDA for Plus 1.

Pre-market Notification Details

• Device ID: K850478
• 510k Number: K850478
• Device Name: PLUS 1
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: DYMAX CORP. 604 EPSILON DR. Pittsburgh, PA 15238
• Contact: Irene R Skolnick
• Correspondent: Irene R Skolnick; DYMAX CORP. 604 EPSILON DR. Pittsburgh, PA 15238
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-02-11
• Decision Date: 1985-04-15