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510(k) K062462

NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L by Jawon Medical Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2006
Date Received
August 24, 2006
Clearance Type
Traditional
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)
  • 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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