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FDA 510(k), K932571, TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
FDA 510(k), K932571, TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
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510(K) Number: K932571
Device Name: TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
Manufacturer: TOMEY CORPORATION USA
Device Classification Name: stimulator, photic, evoked response
Regulation Number: 882.1890
Classification Product Code: GWE
Date Received: 05/27/1993
Decision Date: 08/31/1995
Regulation Medical Specialty: Neurology
Device Name: TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
Manufacturer: TOMEY CORPORATION USA
Device Classification Name: stimulator, photic, evoked response
Regulation Number: 882.1890
Classification Product Code: GWE
Date Received: 05/27/1993
Decision Date: 08/31/1995
Regulation Medical Specialty: Neurology
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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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