LogoFDA 510(k) Search
K Number
K954729

Validate with FDA (Live)

Device Name
PEN-INJECT 2.25
Manufacturer
SCANDINAVIAN HEALTH LTD.
Date Cleared
1996-01-29

(108 days)

Product Code
KZH
Regulation Number
880.6920
Type
Traditional
Panel
General Hospital
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K042557
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 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).