Neuromonitoring Kit— 510(k) K161893

Substantially Equivalent

SI-BONE, Inc.

FDA 510(k) clearance K161893 for Neuromonitoring Kit, Substantially Equivalent on 2016-10-18. Applicant: SI-BONE, Inc..

Clearance details

Applicant: SI-BONE, Inc.
Product code: Code PDQ
Advisory panel: Ear, Nose, Throat
Date received: 2016-07-11
Decision date: 2016-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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