THERMODYN

Pad, Heating, Powered

NEMECTRON MEDICAL, INC.

The following data is part of a premarket notification filed by Nemectron Medical, Inc. with the FDA for Thermodyn.

Pre-market Notification Details

• Device ID: K923396
• 510k Number: K923396
• Device Name: THERMODYN
• Classification: Pad, Heating, Powered
• Applicant: NEMECTRON MEDICAL, INC. 28069 DIAZ RD., UNIT A Temecula, CA 92590
• Contact: Juergen F Kopf
• Correspondent: Juergen F Kopf; NEMECTRON MEDICAL, INC. 28069 DIAZ RD., UNIT A Temecula, CA 92590
• Product Code: IRT
• CFR Regulation Number: 890.5740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-10
• Decision Date: 1993-05-26