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510(k) K012842

V*CARE MANUAL RESUSCITATOR by Ventlab Corp. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2001
Date Received
August 23, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

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  • K063813 — VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA (March 26, 2008)
  • K040726 — VENTLAB NASAL CPAP CANNULA (June 3, 2004)
  • K030271 — VENTLAB BACTERIAL FILTER, MODEL BF100 (July 7, 2003)

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