NMF004A
K-Number: K173500 · 2018-03-08
ApplicantGC America, Inc.
Decision Date2018-03-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
NMF004A is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2018-03-08 under approval number K173500. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NMF004A?
NMF004A is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by GC America, Inc.. The 510(k) number is K173500.
When was NMF004A approved by the FDA?
NMF004A received FDA 510(k) clearance on 2018-03-08, under approval number K173500.
What company makes NMF004A?
NMF004A is manufactured by GC America, Inc..
What is the FDA product code for NMF004A?
The FDA product code for NMF004A is EBF.
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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.