FDA 510(k), K101681, TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
FDA 510(k), K101681, TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
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510(K) Number: K101681
Device Name: TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
Manufacturer: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: 870.1130
Classification Product Code: DXN
Date Received: 06/15/2010
Decision Date: 05/27/2011
Regulation Medical Specialty: Cardiovascular
Device Name: TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
Manufacturer: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: 870.1130
Classification Product Code: DXN
Date Received: 06/15/2010
Decision Date: 05/27/2011
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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