Bigfoot Unity Diabetes Management System

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Bigfoot Biomedical, Inc.

The following data is part of a premarket notification filed by Bigfoot Biomedical, Inc. with the FDA for Bigfoot Unity Diabetes Management System.

Pre-market Notification Details

• Device ID: K202145
• 510k Number: K202145
• Device Name: Bigfoot Unity Diabetes Management System
• Classification: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
• Applicant: Bigfoot Biomedical, Inc. 1820 McCarthy Blvd Milpitas, CA 95035
• Contact: Kate Lee
• Correspondent: Kate Lee; Bigfoot Biomedical, Inc. 1820 McCarthy Blvd Milpitas, CA 95035
• Product Code: QLG
• CFR Regulation Number: 862.1355 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-07-31
• Decision Date: 2021-05-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850003506579	K202145	000
00850003506685	K202145	000
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