C015
K-Number: K192182 · 2020-01-17
ApplicantMicronica Srl
Decision Date2020-01-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
C015 is the device name listed in this FDA 510(k) record. The listed applicant is Micronica Srl. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192182. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the C015?
C015 is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Micronica Srl. The 510(k) number is K192182.
When did C015 receive FDA 510(k) clearance?
C015 received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192182.
Who is the listed applicant for C015?
The FDA 510(k) record lists Micronica Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for C015?
The FDA product code for C015 is OWB.
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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.