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FDA 510(k), K040002, MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
FDA 510(k), K040002, MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
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510(K) Number: K040002
Device Name: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
Manufacturer: SUSAN D GOLDSTEIN-FALK
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: 01/02/2004
Date Received: 03/22/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
Manufacturer: SUSAN D GOLDSTEIN-FALK
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: 01/02/2004
Date Received: 03/22/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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