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510(k) K024077

DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR by Zewa, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2003
Date Received
December 10, 2002
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.

  • K041491 — ZEWA MFM-007 BLOOD PRESSURE MONITOR (September 20, 2004)
  • K952765 — DELWA-STAR PACIFIER THERMOMETER (October 13, 1995)
  • K921189 — THERMA-H (August 31, 1992)

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