K Number
K960401Device Name
ULTIMATE SEALManufacturer
Date Cleared
1996-06-20
(143 days)
Product Code
Regulation Number
868.5570Type
TraditionalPanel
ANReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 868.5570 Nonrebreathing mask.
(a)
Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.(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.