NovoPen Echo
K-Number: K162602 · 2016-10-18
ApplicantNovo Nordisk, Inc.
Decision Date2016-10-18
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NovoPen Echo is a medical device manufactured by Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2016-10-18 under approval number K162602. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NovoPen Echo?
NovoPen Echo is a medical device that received FDA 510(k) clearance on 2016-10-18. It is manufactured by Novo Nordisk, Inc.. The 510(k) number is K162602.
When was NovoPen Echo approved by the FDA?
NovoPen Echo received FDA 510(k) clearance on 2016-10-18, under approval number K162602.
What company makes NovoPen Echo?
NovoPen Echo is manufactured by Novo Nordisk, Inc..
What is the FDA product code for NovoPen Echo?
The FDA product code for NovoPen Echo is FMF.
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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.