HOT SHOT

System, Imaging, Pulsed Echo, Ultrasonic

SCHIFF PHOTO MECHANICS

The following data is part of a premarket notification filed by Schiff Photo Mechanics with the FDA for Hot Shot.

Pre-market Notification Details

• Device ID: K833233
• 510k Number: K833233
• Device Name: HOT SHOT
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: SCHIFF PHOTO MECHANICS 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-09-07
• Decision Date: 1983-10-28