PEN-INJECT 2.25 by SCANDINAVIAN HEALTH LTD. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

PEN-INJECT 2.25

Manufacturer

SCANDINAVIAN HEALTH LTD.

Date Cleared

1996-01-29

(108 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

Intended Use

Device Description

AI/ML Overview

Summary

Regulation Number and Section

§ 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).