Decision Date1993-02-25
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
FRESENIUS VARIABLE FILL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1993-02-25 under 510(k) number K921052. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FRESENIUS VARIABLE FILL MONITOR?
FRESENIUS VARIABLE FILL MONITOR is a medical device that received FDA 510(k) clearance on 1993-02-25. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K921052.
When did FRESENIUS VARIABLE FILL MONITOR receive FDA 510(k) clearance?
FRESENIUS VARIABLE FILL MONITOR received FDA 510(k) clearance on 1993-02-25, under 510(k) number K921052.
Who is the listed applicant for FRESENIUS VARIABLE FILL MONITOR?
The FDA 510(k) record lists Fresenius USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FRESENIUS VARIABLE FILL MONITOR?
The FDA product code for FRESENIUS VARIABLE FILL MONITOR is KDJ.
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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.