VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER

Monitor, Airway Pressure (includes Gauge And/or Alarm)

VENTLAB CORP.

The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Pressurechek Disosable Column Manometer.

Pre-market Notification Details

Device IDK120118
510k NumberK120118
Device Name:VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant VENTLAB CORP. 155 BOYCE DRIVE Mocksville,  NC  27028
ContactJames A Cochie
CorrespondentJames A Cochie
VENTLAB CORP. 155 BOYCE DRIVE Mocksville,  NC  27028
Product CodeCAP  
CFR Regulation Number868.2600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-17
Decision Date2012-05-24

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