K Number
K001430Device Name
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
Manufacturer
Date Cleared
2000-07-05
(61 days)
Product Code
Regulation Number
868.5925AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
N/A