CapsoCam Plus (SV-3)

System, Imaging, Gastrointestinal, Wireless, Capsule

CapsoVision, Inc.

The following data is part of a premarket notification filed by Capsovision, Inc. with the FDA for Capsocam Plus (sv-3).

Pre-market Notification Details

Device IDK183192
510k NumberK183192
Device Name:CapsoCam Plus (SV-3)
ClassificationSystem, Imaging, Gastrointestinal, Wireless, Capsule
Applicant CapsoVision, Inc. 18805 Cox Avenue, Suite 250 Saratoga,  CA  95070
ContactAzimun Jamal
CorrespondentAzimun Jamal
CapsoVision, Inc. 18805 Cox Avenue, Suite 250 Saratoga,  CA  95070
Product CodeNEZ  
CFR Regulation Number876.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2019-04-19

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