FDA 510(k), K121590, VESTIBULAR ANALYSIS APPARATUS

FDA 510(k), K121590, VESTIBULAR ANALYSIS APPARATUS

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510(K) Number: K121590
Device Name: VESTIBULAR ANALYSIS APPARATUS
Manufacturer: PAMELA M BUCKMAN
Device Classification Name: Apparatus, Vestibular Analysis
Regulation Number: LXV
Classification Product Code: KXA
Date Received: 05/31/2012
Decision Date: 09/20/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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