510(k) K042003

INFINITY TRIDENT NMT POD by Draeger Medical Systems, Inc. — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2004
Date Received
July 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type