NOVATHERM

System, Thermographic, Liquid Crystal, Powered (adjunctive Use)

MED TECH PRODUCTS, INC.

The following data is part of a premarket notification filed by Med Tech Products, Inc. with the FDA for Novatherm.

Pre-market Notification Details

• Device ID: K851034
• 510k Number: K851034
• Device Name: NOVATHERM
• Classification: System, Thermographic, Liquid Crystal, Powered (adjunctive Use)
• Applicant: MED TECH PRODUCTS, INC. MCDERMOTT, WILL & EMERY 1850 K STREET NW Washington, DC 20006
• Contact: William D Appler
• Correspondent: William D Appler; MED TECH PRODUCTS, INC. MCDERMOTT, WILL & EMERY 1850 K STREET NW Washington, DC 20006
• Product Code: KXZ
• CFR Regulation Number: 884.2982 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-03-13
• Decision Date: 1985-09-27