AggreGuide A-100 ADP
K-Number: K181777 · 2019-03-29
ApplicantAggredyne, Inc.
Decision Date2019-03-29
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
AggreGuide A-100 ADP is a medical device manufactured by Aggredyne, Inc.. It received FDA 510(k) clearance on 2019-03-29 under approval number K181777. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AggreGuide A-100 ADP?
AggreGuide A-100 ADP is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Aggredyne, Inc.. The 510(k) number is K181777.
When was AggreGuide A-100 ADP approved by the FDA?
AggreGuide A-100 ADP received FDA 510(k) clearance on 2019-03-29, under approval number K181777.
What company makes AggreGuide A-100 ADP?
AggreGuide A-100 ADP is manufactured by Aggredyne, Inc..
What is the FDA product code for AggreGuide A-100 ADP?
The FDA product code for AggreGuide A-100 ADP is JOZ.
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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.