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510(k) K052438

EMG HANDLE NEBULIZER NB02 SERIES by Emg Technology Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2006
Date Received
September 6, 2005
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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  • K042349 — EMG MODEL SUA01 SUCTION UNIT (December 16, 2004)
  • K033206 — EPW FOLDABLE POWER WHEELCHAIR, EPW-03 (December 18, 2003)
  • K033204 — ESG 4-WHEEL SCOOTER, ESG-03 (November 12, 2003)
  • K023148 — EPW POWERED WHEELCHAIR, GP-201 (January 24, 2003)

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