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510(k) K040862

GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM by Caradyne, Ltd. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2004
Date Received
April 2, 2004
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

Other clearances by Caradyne, Ltd.

  • K023565 — OXICHECK (March 28, 2003)
  • K000959 — CRITERION 60 OR PM 60 (June 22, 2000)
  • K992101 — CRITERION 40 OR PM 40 (January 6, 2000)
  • K982283 — WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN (March 9, 1999)

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