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510(k) K140762

AUTOMATIC BLOOD PRESSURE MONITOR by Jawon Medical Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2015
Date Received
March 27, 2014
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 Jawon Medical Co., Ltd.

  • K140045 — BODY COMPOSITION ANALYZER (February 18, 2015)
  • K092432 — AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) (October 9, 2009)
  • K092431 — BODY COMPOSITION ANALYZER, MODEL: IOI 353 (October 8, 2009)
  • K072325 — BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 (November 30, 2007)
  • K071884 — BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, (August 9, 2007)
  • K062462 — NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L (September 29, 2006)
  • K053556 — BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 (August 31, 2006)
  • K013876 — INFRARED EAR THERMOMETER, MODEL DX-707 (March 4, 2002)
  • K002722 — DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 (September 11, 2000)
  • K000675 — MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 (March 14, 2000)

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