SURETEMP

Thermometer, Electronic, Clinical

DIATEK INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Diatek Instruments, Inc. with the FDA for Suretemp.

Pre-market Notification Details

• Device ID: K964643
• 510k Number: K964643
• Device Name: SURETEMP
• Classification: Thermometer, Electronic, Clinical
• Applicant: DIATEK INSTRUMENTS, INC. 7420 CARROLL RD. San Diego, CA 92121
• Contact: Thomas Gregory
• Correspondent: Thomas Gregory; DIATEK INSTRUMENTS, INC. 7420 CARROLL RD. San Diego, CA 92121
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-11-12
• Decision Date: 1997-01-09