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K Number
K971645
Device Name
REGANES SPINAL NEEDLE (VARIOUS)
Manufacturer
AVID N.I.T., INC.
Date Cleared
1997-08-01

(88 days)

Product Code
MIA
Regulation Number
868.5150
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).