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K Number
K970046
Device Name
UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
Manufacturer
ACCUTRON, INC.
Date Cleared
1997-03-28

(81 days)

Product Code
KHA
Regulation Number
868.5590
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5590 Scavenging mask.

(a)
Identification. A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry.(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.