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510(k) K022642

TWLIGHT, MODEL ISP 9600 by Invacare Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2003
Date Received
August 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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  • K023589 — STORM TDX POWER WHEELCHAIR (November 19, 2002)
  • K021685 — VENTURE HOMEFILL II WITH OXYGEN CONSERVER (July 23, 2002)

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