Circa S-Cath M Esophageal Temperature Probe And Temperature Monitoring System

Thermometer, Electronic, Clinical

CIRCA Scientific, LLC

The following data is part of a premarket notification filed by Circa Scientific, Llc with the FDA for Circa S-cath M Esophageal Temperature Probe And Temperature Monitoring System.

Pre-market Notification Details

• Device ID: K200943
• 510k Number: K200943
• Device Name: Circa S-Cath M Esophageal Temperature Probe And Temperature Monitoring System
• Classification: Thermometer, Electronic, Clinical
• Applicant: CIRCA Scientific, LLC 14 Inverness Drive East, Suite H-136 Englewood, CO 80112
• Contact: Fred Piazza
• Correspondent: Fred Piazza; CIRCA Scientific, LLC 14 Inverness Drive East, Suite H-136 Englewood, CO 80112
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-08
• Decision Date: 2021-12-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10851498007111	K200943	000
00851498007121	K200943	000
00860237000293	K200943	000