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510(k) Data Aggregation
K Number
K110119Device Name
PRESSURE MANOMETER
Manufacturer
NEOFORCE GROUP INC
Date Cleared
2011-06-10
(143 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Applicant Name (Manufacturer) :
NEOFORCE GROUP INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pressure Manometer is used to provide visual indication of patient's airway pressure during ventilation. It may be attached by flexible tubing to devices providing expiratory pressure such as resuscitation bags, hyperinflation bags, CPAP Masks or Circuits.
Device Description
The NF-009 Pressure Manometer is a low pressure gauge with a range of -20 to 80 cmH2O in marked increments of 1 cm H2O. The gauge has color coding green, yellow and red. The Manometer provides visual indication of airway pressure during ventilation or resuscitation.
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