Hemosense, Inc.

Medical device manufacturer in San Jose, CA.

3510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K072727Inratio 2 PT Monitoring SystemGJS · Special 10/26/2007SE
K021923Inratio Self-TestGJS · Traditional 10/24/2002SE
K020679InratioGJS · Traditional 05/06/2002SE

Recalls

RecallProductInitiated
Z-1256-2009 HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The…INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors… 12/23/2008Terminated