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510(k) K041491

ZEWA MFM-007 BLOOD PRESSURE MONITOR by Zewa, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2004
Date Received
June 4, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Zewa, Inc.

  • K024077 — DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR (March 10, 2003)
  • K952765 — DELWA-STAR PACIFIER THERMOMETER (October 13, 1995)
  • K921189 — THERMA-H (August 31, 1992)

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