Decision Date2012-09-25
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CHF-Y0005 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2012-09-25 under 510(k) number K113120. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CHF-Y0005?
CHF-Y0005 is a medical device that received FDA 510(k) clearance on 2012-09-25. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K113120.
When did CHF-Y0005 receive FDA 510(k) clearance?
CHF-Y0005 received FDA 510(k) clearance on 2012-09-25, under 510(k) number K113120.
Who is the listed applicant for CHF-Y0005?
The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CHF-Y0005?
The FDA product code for CHF-Y0005 is FBN.
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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.