Home / 510(k) Clearances / K012530

510(k) K012530

AA-1 SYSTEM by Neurovision, Inc. — Product Code HJT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 31, 2001
Date Received: August 6, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Haploscope
Device Class: Class I
Regulation Number: 886.1340
Review Panel: OP
Submission Type