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510(k) K132138

RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE by Rhythmlink International, LLC — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2014
Date Received
July 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Nerve Locator
Device Class
Class II
Regulation Number
874.1820
Review Panel
NE
Submission Type

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

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  • K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (September 22, 2011)

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