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K Number
K000959
Device Name
CRITERION 60 OR PM 60
Manufacturer
CARADYNE, LTD.
Date Cleared
2000-06-22

(90 days)

Product Code
CAP
Regulation Number
868.2600
Type
Abbreviated
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.2600 Airway pressure monitor.

(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).