Medicon Vipair High Speed System

FDA 510(k) K042974 · Medicon EG

Substantially Equivalent

510(k) numberK042974

Submission

Device name
Medicon Vipair High Speed System
Applicant
Medicon EG
Tuttlingen, DE
Received
October 28, 2004
Decision date
January 13, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBB – Motor, Drill, Pneumatic
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4370
Specialty
Neurology

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Questions and answers

When was Medicon Vipair High Speed System cleared by the FDA?

Medicon Vipair High Speed System (K042974) received a 510(k) decision of Substantially Equivalent on January 13, 2005, 77 days after the submission was received.

What is the product code of K042974?

The FDA product code is HBB – Motor, Drill, Pneumatic, a Class II (moderate risk) device regulated under 21 CFR 882.4370.