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510(k) K121520

ULTRASONIC NEBULIZER (MESH TYPE) by K-Jump Health Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2013
Date Received
May 22, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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  • K083256 — ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 (June 26, 2009)
  • K083753 — SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY F (June 19, 2009)

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