CAPENERGY - C100, C200, C300, C400, C50
K-Number: K191202 · 2020-02-11
ApplicantCapenergy Medical S.L.
Decision Date2020-02-11
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CAPENERGY - C100, C200, C300, C400, C50 is a medical device manufactured by Capenergy Medical S.L.. It received FDA 510(k) clearance on 2020-02-11 under approval number K191202. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CAPENERGY - C100, C200, C300, C400, C50?
CAPENERGY - C100, C200, C300, C400, C50 is a medical device that received FDA 510(k) clearance on 2020-02-11. It is manufactured by Capenergy Medical S.L.. The 510(k) number is K191202.
When was CAPENERGY - C100, C200, C300, C400, C50 approved by the FDA?
CAPENERGY - C100, C200, C300, C400, C50 received FDA 510(k) clearance on 2020-02-11, under approval number K191202.
What company makes CAPENERGY - C100, C200, C300, C400, C50?
CAPENERGY - C100, C200, C300, C400, C50 is manufactured by Capenergy Medical S.L..
What is the FDA product code for CAPENERGY - C100, C200, C300, C400, C50?
The FDA product code for CAPENERGY - C100, C200, C300, C400, C50 is PBX.
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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.