SURETEMP

Thermometer, Electronic, Clinical

ADVANCED BIORESEARCH ASSOC.

The following data is part of a premarket notification filed by Advanced Bioresearch Assoc. with the FDA for Suretemp.

Pre-market Notification Details

• Device ID: K943695
• 510k Number: K943695
• Device Name: SURETEMP
• Classification: Thermometer, Electronic, Clinical
• Applicant: ADVANCED BIORESEARCH ASSOC. 3377 NORTH TORREY PINES CT. SUITE 300 Lajolla, CA 92037
• Contact: Hal Siegel
• Correspondent: Hal Siegel; ADVANCED BIORESEARCH ASSOC. 3377 NORTH TORREY PINES CT. SUITE 300 Lajolla, CA 92037
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-29
• Decision Date: 1995-04-21