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FDA 510(k), K042506, OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
FDA 510(k), K042506, OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
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510(K) Number: K042506
Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
Manufacturer: IWAO KOJIMA
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: 09/15/2004
Date Received: 04/05/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
Manufacturer: IWAO KOJIMA
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: 09/15/2004
Date Received: 04/05/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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