K Number
K961309
Device Name
POS-T-VAC ID-300
Manufacturer
Date Cleared
1996-06-10

(67 days)

Product Code
Regulation Number
880.6920
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 880.6920 Syringe needle introducer.

(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).