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510(k) K062664

HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 by Apex Medical Corp. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2006
Date Received
September 7, 2006
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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  • K103174 — APEX MEDICAL WIZARD SERIES CPAP MASK (May 6, 2011)
  • K103535 — VACPLUS SUCTION UNIT (February 24, 2011)

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