Decision Date1993-01-28
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
DIGI -FLOW is the device name listed in this FDA 510(k) record. The listed applicant is D and D Technology, Inc.. It received FDA 510(k) clearance on 1993-01-28 under 510(k) number K920671. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DIGI -FLOW?
DIGI -FLOW is a medical device that received FDA 510(k) clearance on 1993-01-28. The listed applicant is D and D Technology, Inc.. The 510(k) number is K920671.
When did DIGI -FLOW receive FDA 510(k) clearance?
DIGI -FLOW received FDA 510(k) clearance on 1993-01-28, under 510(k) number K920671.
Who is the listed applicant for DIGI -FLOW?
The FDA 510(k) record lists D and D Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DIGI -FLOW?
The FDA product code for DIGI -FLOW is KOC.
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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.