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510(k) K002722

DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 by Jawon Medical Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2000
Date Received
August 31, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

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.

  • K140762 — AUTOMATIC BLOOD PRESSURE MONITOR (July 2, 2015)
  • 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)
  • K000675 — MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 (March 14, 2000)

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