Thermofit

Accelerator, Linear, Medical

ORFIT INDUSTRIES

The following data is part of a premarket notification filed by Orfit Industries with the FDA for Thermofit.

Pre-market Notification Details

• Device ID: K151946
• 510k Number: K151946
• Device Name: Thermofit
• Classification: Accelerator, Linear, Medical
• Applicant: ORFIT INDUSTRIES VOSVELD 9A, B-2110 WIJNEGEM Wijnegem, Belgium, BE
• Contact: Eddy Marovoet
• Correspondent: Lee Leichter; P/L BIOMEDICAL 10882 STONINGTON AVE Fort Myers, FL 33913
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-14
• Decision Date: 2015-11-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05420028769355	K151946	000
05420028707647	K151946	000