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510(k) K031176

INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 by Invacare Corp. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2004
Date Received
April 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

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  • K033819 — INVACARE 3G TARSYS (June 4, 2004)
  • K031064 — INVACARE POLARIS EX CPAP, MODEL ISP3000 (March 12, 2004)
  • K030814 — INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 (March 20, 2003)
  • K022642 — TWLIGHT, MODEL ISP 9600 (February 11, 2003)
  • K023589 — STORM TDX POWER WHEELCHAIR (November 19, 2002)
  • K021685 — VENTURE HOMEFILL II WITH OXYGEN CONSERVER (July 23, 2002)

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