Resascope RS-01/B
K-Number: K201113 · 2020-12-21
ApplicantAdvanced Medical Systems Group Srl
Decision Date2020-12-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Resascope RS-01/B is a medical device manufactured by Advanced Medical Systems Group Srl. It received FDA 510(k) clearance on 2020-12-21 under approval number K201113. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Resascope RS-01/B?
Resascope RS-01/B is a medical device that received FDA 510(k) clearance on 2020-12-21. It is manufactured by Advanced Medical Systems Group Srl. The 510(k) number is K201113.
When was Resascope RS-01/B approved by the FDA?
Resascope RS-01/B received FDA 510(k) clearance on 2020-12-21, under approval number K201113.
What company makes Resascope RS-01/B?
Resascope RS-01/B is manufactured by Advanced Medical Systems Group Srl.
What is the FDA product code for Resascope RS-01/B?
The FDA product code for Resascope RS-01/B is HRX.
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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.