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510(k) K861375

MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS by Sharp Electronics Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1986
Date Received
January 27, 1986
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 Sharp Electronics Corp.

  • K880715 — (MB-650) BLOOD PRESSURE MONITOR (May 9, 1988)
  • K875093 — NEW MODEL MB-550 BLOOD PRESSURE MONITOR (February 5, 1988)
  • K863672 — MODEL (MB-700) BLOOD PRESSURE MONITOR (November 18, 1986)
  • K862333 — (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS (July 8, 1986)
  • K852194 — MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET (September 27, 1985)
  • K851664 — MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO (July 24, 1985)
  • K850830 — SHARP DIGITAL BP MONITOR MB-371H (June 13, 1985)
  • K842200 — MD308H DIGITAL/MB351H AUTO-BP MONITOR (October 24, 1984)
  • K842199 — ELEC. DIGITAL THERMOMETER MT-20 & 30 (July 18, 1984)

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