Visor System

Impedance Plethysmograph, Cranial

Cerebrotech Medical Systems, Inc.

The following data is part of a premarket notification filed by Cerebrotech Medical Systems, Inc. with the FDA for Visor System.

Pre-market Notification Details

Device IDK182967
510k NumberK182967
Device Name:Visor System
ClassificationImpedance Plethysmograph, Cranial
Applicant Cerebrotech Medical Systems, Inc. 1048 Serpentine Lane Suite 301 Pleasanton,  CA  94566
ContactDawnel Scott
CorrespondentDawnel Scott
Cerebrotech Medical Systems, Inc. 1048 Serpentine Lane Suite 301 Pleasanton,  CA  94566
Product CodeQAF  
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-26
Decision Date2018-11-23
Summary:summary

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