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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K120118
Device Name VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
Applicant
Ventlab Corp.
155 Boyce Dr.
Mocksville,  NC  27028
Applicant Contact JAMES A COCHIE
Correspondent
Ventlab Corp.
155 Boyce Dr.
Mocksville,  NC  27028
Correspondent Contact JAMES A COCHIE
Regulation Number868.2600
Classification Product Code
CAP  
Date Received01/17/2012
Decision Date 05/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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