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510(k) Data Aggregation
K Number
K091853Device Name
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
Manufacturer
NSPIRE HEALTH, INC.
Date Cleared
2009-09-21
(90 days)
Product Code
BZK, REG
Regulation Number
868.1850Why did this record match?
Applicant Name (Manufacturer) :
NSPIRE HEALTH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery.
It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.
Device Description
The Respirometer is a mechanically driven dial, where the dial indicates gas volume passed, and the mechanism is driven by the kinetic energy in the flowing gas. The device measures expirate gas flow and measurements are unaffected by inspirate gas flow. It has an on/off button to lock the pointer and a reset button to return the pointer to zero when it approaches full scale
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