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K Number
K963298
Device Name
FIRST AID KIT(S)
Manufacturer
VECTOR, INC.
Date Cleared
1996-11-06

(77 days)

Product Code
BYG
Regulation Number
868.5580
Type
Traditional
Panel
AN
Reference & 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.