B6
K-Number: K163429 · 2017-01-04
Decision Date2017-01-04
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
B6 is a medical device manufactured by Beijing East Whale Imaging Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-01-04 under approval number K163429. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the B6?
B6 is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by Beijing East Whale Imaging Technology Co., Ltd.. The 510(k) number is K163429.
When was B6 approved by the FDA?
B6 received FDA 510(k) clearance on 2017-01-04, under approval number K163429.
What company makes B6?
B6 is manufactured by Beijing East Whale Imaging Technology Co., Ltd..
What is the FDA product code for B6?
The FDA product code for B6 is OXO.
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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.