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510(k) K043238

COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES by Emg Technology Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2005
Date Received
November 22, 2004
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

Other clearances by Emg Technology Co., Ltd.

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  • K052438 — EMG HANDLE NEBULIZER NB02 SERIES (January 31, 2006)
  • K043520 — EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR (October 21, 2005)
  • 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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