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510(k) K001467

DA VINCHI EMG/EP ISA1004EP by Airsep Corp. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2000
Date Received
May 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

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  • K983002 — MYSTIQUE ULTRASONIC NEBULIZER (October 16, 1998)
  • K960309 — AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) (February 28, 1997)

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