CapsoCam (SV-1)
K-Number: K151635 · 2016-02-09
ApplicantCapsoVision, Inc.
Decision Date2016-02-09
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CapsoCam (SV-1) is a medical device manufactured by CapsoVision, Inc.. It received FDA 510(k) clearance on 2016-02-09 under approval number K151635. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CapsoCam (SV-1)?
CapsoCam (SV-1) is a medical device that received FDA 510(k) clearance on 2016-02-09. It is manufactured by CapsoVision, Inc.. The 510(k) number is K151635.
When was CapsoCam (SV-1) approved by the FDA?
CapsoCam (SV-1) received FDA 510(k) clearance on 2016-02-09, under approval number K151635.
What company makes CapsoCam (SV-1)?
CapsoCam (SV-1) is manufactured by CapsoVision, Inc..
What is the FDA product code for CapsoCam (SV-1)?
The FDA product code for CapsoCam (SV-1) is NEZ.
Other Devices by CapsoVision, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.