Home / 510(k) Clearances / K880715

510(k) K880715

(MB-650) BLOOD PRESSURE MONITOR by Sharp Electronics Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1988
Date Received
February 9, 1988
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.

  • K875093 — NEW MODEL MB-550 BLOOD PRESSURE MONITOR (February 5, 1988)
  • K863672 — MODEL (MB-700) BLOOD PRESSURE MONITOR (November 18, 1986)
  • K861375 — MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS (August 6, 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)

Other clearances for product code DXN

  • K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (March 5, 2026)
  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (January 12, 2026)
  • K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (January 9, 2026)
  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
  • K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (October 9, 2025)