K Number
K962848Device Name
HANS RUDOLPH NASAL CPAP MASKManufacturer
Date Cleared
1996-10-16
(86 days)
Product Code
Regulation Number
868.5580Type
TraditionalPanel
ANReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 868.5580 Oxygen mask.
(a)
Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.