Sentinel
K-Number: K200600 · 2020-04-20
ApplicantC-Rad Positioning AB
Decision Date2020-04-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sentinel is a medical device manufactured by C-Rad Positioning AB. It received FDA 510(k) clearance on 2020-04-20 under approval number K200600. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sentinel?
Sentinel is a medical device that received FDA 510(k) clearance on 2020-04-20. It is manufactured by C-Rad Positioning AB. The 510(k) number is K200600.
When was Sentinel approved by the FDA?
Sentinel received FDA 510(k) clearance on 2020-04-20, under approval number K200600.
What company makes Sentinel?
Sentinel is manufactured by C-Rad Positioning AB.
What is the FDA product code for Sentinel?
The FDA product code for Sentinel is IYE.
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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.