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510(k) K101154

CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L by Airsep Corp. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2011
Date Received
April 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Airsep Corp.

  • K080348 — OXISCAN II DATA MANAGEMENT SYSTEM (October 9, 2008)
  • K020324 — LIFESTYLE OXYGEN CONCENTRATOR (March 13, 2002)
  • K012037 — HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 (January 17, 2002)
  • K000963 — DA VINCHI EEG AND EMG/EP SYSTEMS (October 20, 2000)
  • K001579 — IMPULSE SELECT (August 31, 2000)
  • K001467 — DA VINCHI EMG/EP ISA1004EP (August 1, 2000)
  • K001013 — MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (May 16, 2000)
  • K992283 — ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (August 27, 1999)
  • K983002 — MYSTIQUE ULTRASONIC NEBULIZER (October 16, 1998)
  • K960309 — AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) (February 28, 1997)

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