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510(k) K072634

EMG TRITON -COMP,MODEL NCA01-XXX SERIES by Emg Technology Co., Ltd. — Product Code BTI

K072634 is an FDA 510(k) premarket notification submitted by Emg Technology Co., Ltd. for the device "EMG TRITON -COMP,MODEL NCA01-XXX SERIES". The FDA issued a decision of Substantially Equivalent on November 19, 2008. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Emg Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2008
Date Received
September 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

Other clearances by Emg Technology Co., Ltd.

  • K112421 — EMG SUCTION UNIT (September 1, 2011)
  • K063448 — EMG AC/DC SUCTION UNIT (November 30, 2006)
  • K062888 — MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 (October 24, 2006)
  • K052438 — EMG HANDLE NEBULIZER NB02 SERIES (January 31, 2006)
  • K043520 — EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR (October 21, 2005)
  • K043238 — COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES (July 6, 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)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)
  • K031686 — AEROMIST LT, MODEL HCS15004 (January 21, 2004)

FDA data resources