Paragon 2
K-Number: K162687 · 2016-10-21
ApplicantMeridian Medical Systems, LLC
Decision Date2016-10-21
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Paragon 2 is a medical device manufactured by Meridian Medical Systems, LLC. It received FDA 510(k) clearance on 2016-10-21 under approval number K162687. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Paragon 2?
Paragon 2 is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Meridian Medical Systems, LLC. The 510(k) number is K162687.
When was Paragon 2 approved by the FDA?
Paragon 2 received FDA 510(k) clearance on 2016-10-21, under approval number K162687.
What company makes Paragon 2?
Paragon 2 is manufactured by Meridian Medical Systems, LLC.
What is the FDA product code for Paragon 2?
The FDA product code for Paragon 2 is IZL.
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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.