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510(k) K071347

VAX-D GENESIS G2 SYSTEM by Vax-D Medical Technologies, LLC — Product Code ITH

K071347 is an FDA 510(k) premarket notification submitted by Vax-D Medical Technologies, LLC for the device "VAX-D GENESIS G2 SYSTEM". The FDA issued a decision of Substantially Equivalent on October 5, 2007. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2007
Date Received
May 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

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FDA data resources