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510(k) K000963

DA VINCHI EEG AND EMG/EP SYSTEMS by Airsep Corp. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2000
Date Received
March 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Airsep Corp.

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  • K020324 — LIFESTYLE OXYGEN CONCENTRATOR (March 13, 2002)
  • K012037 — HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 (January 17, 2002)
  • 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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