Decision Date2013-10-08
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
R7 is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2013-10-08 under 510(k) number K130834. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the R7?
R7 is a medical device that received FDA 510(k) clearance on 2013-10-08. The listed applicant is Cefla S.C.. The 510(k) number is K130834.
When did R7 receive FDA 510(k) clearance?
R7 received FDA 510(k) clearance on 2013-10-08, under 510(k) number K130834.
Who is the listed applicant for R7?
The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for R7?
The FDA product code for R7 is ELC.
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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.