WebPhilosys Gmate SMART (k131230) Predicate device AgaMatrix, Inc. iBGStar (k103544) Test Time 5 seconds 6 seconds Software . Gmate SMART Application iBGStar Diabetes Manager Application Dimensions: LxWxH (mm) 43x21x9 ; 55x24x10 . Weight ; 4.2 g (without iOS device) 42 g . WebPHILOSYS, INC. LINDA CHAN MANAGER 304 PARK AVENUE SOUTH, SUITE 218 NEW YORK NY 10016 Re: K151658 Trade/Device Name: Gmate® Origin Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: October 14, 2015
DEPARTMENT OF HEALTH & HUMAN SERVICES
WebGmate® ON. Gmate On has audio guidance function for instruction as well as test … WebPHILOSYS, INC. C/O LINDA CHAN PHILOSYS, INC 304 PARK AVENUE SOUTH, SUITE 218 NEW YORK NY 10010 Re: K131230 Trade/Device Name: Gmate® SMART Blood Glucose Monitoring System, Gmate® SMART Application Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: … i see clearly now wubbzy
Gmate Check Philosys Co.,Ltd. - Omnia Health
WebScalability - Expand its application to various Gmate® Rapid Tests. Convenience - Specifically designed for Hospital/Clinic-level use with Barcode/QR scanner. Performance Android 11. Wi-Fi 2.4GHz. Bluetooth v5.0. Capacitive Touch Screen. Screen Resolution 720 x 1600 pixels. Size 212.8 x 108 x 75.8 mm. WebAug 2, 2012 · NEW YORK, Aug. 2, 2012 /PRNewswire/ -- Philosys announced today that it has applied for approval from the U.S. Food and Drug Administration (FDA) for its Gmate® blood glucose monitoring system in ... WebJul 23, 2024 · One of the self-test kits, GMate Covid-19 Ag Saliva Home Kit (made in Korea) is now available for purchase at Sunlight Pharmacy at RM39.90 each. GMate is manufactured by the Philosys Co Ltd, South ... i see clearly now