IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM

Glucose Oxidase, Glucose

EOSHEALTH, INC.

The following data is part of a premarket notification filed by Eoshealth, Inc. with the FDA for In Touch Blood Glucose Monitoring System.

Pre-market Notification Details

• Device ID: K133584
• 510k Number: K133584
• Device Name: IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
• Classification: Glucose Oxidase, Glucose
• Applicant: EOSHEALTH, INC. 816 CONGRESS AVE, STE 1400 Austin, TX 78701
• Contact: Carrie Hetrick
• Correspondent: Carrie Hetrick; EOSHEALTH, INC. 816 CONGRESS AVE, STE 1400 Austin, TX 78701
• Product Code: CGA
• Subsequent Product Code: JJX
• Subsequent Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-21
• Decision Date: 2014-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00853553005417	K133584	000
00853553005141	K133584	000
00853553005110	K133584	000
00853553005097	K133584	000
00853553005066	K133584	000
00853553005059	K133584	000
00853553005035	K133584	000
00853553005028	K133584	000
00853553005004	K133584	000
00853553005011	K133584	000
00853553005738	K133584	000
00810079240494	K133584	000
00810079240470	K133584	000
00810079240463	K133584	000
00810079240432	K133584	000
00853553005158	K133584	000
00853553005189	K133584	000
00853553005196	K133584	000
00853553005400	K133584	000
00853553005349	K133584	000
00853553005325	K133584	000
00853553005318	K133584	000
00853553005301	K133584	000
00853553005295	K133584	000
00853553005288	K133584	000
00853553005271	K133584	000
00853553005257	K133584	000
00853553005240	K133584	000
00853553005233	K133584	000
00853553005226	K133584	000
00853553005219	K133584	000
00853553005202	K133584	000
00810079240142	K133584	000