ALLIVE
K-Number: K192773 · 2019-12-06
ApplicantNu Eyne Co., Ltd.
Decision Date2019-12-06
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ALLIVE is a medical device manufactured by Nu Eyne Co., Ltd.. It received FDA 510(k) clearance on 2019-12-06 under approval number K192773. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ALLIVE?
ALLIVE is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Nu Eyne Co., Ltd.. The 510(k) number is K192773.
When was ALLIVE approved by the FDA?
ALLIVE received FDA 510(k) clearance on 2019-12-06, under approval number K192773.
What company makes ALLIVE?
ALLIVE is manufactured by Nu Eyne Co., Ltd..
What is the FDA product code for ALLIVE?
The FDA product code for ALLIVE is PCC.
Other Devices by Nu Eyne Co., Ltd.
Related Devices (Code: PCC)
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.