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510(k) K043531

MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 by K-Jump Health Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2005
Date Received
December 21, 2004
Clearance Type
Special
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

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  • K092806 — AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 (October 9, 2009)
  • K083256 — ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 (June 26, 2009)

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