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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: 05/31/2012
Date Received: 09/20/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: VESTIBULAR ANALYSIS APPARATUS
Manufacturer: PAMELA M BUCKMAN
Device Classification Name: Apparatus, Vestibular Analysis
Regulation Number: LXV
Classification Product Code: 05/31/2012
Date Received: 09/20/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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