ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
K-Number: K213497 · 2021-11-15
ApplicantH&abyz Co., Ltd.
Decision Date2021-11-15
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) is a medical device manufactured by H&abyz Co., Ltd.. It received FDA 510(k) clearance on 2021-11-15 under approval number K213497. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)?
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) is a medical device that received FDA 510(k) clearance on 2021-11-15. It is manufactured by H&abyz Co., Ltd.. The 510(k) number is K213497.
When was ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) approved by the FDA?
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) received FDA 510(k) clearance on 2021-11-15, under approval number K213497.
What company makes ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)?
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) is manufactured by H&abyz Co., Ltd..
What is the FDA product code for ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)?
The FDA product code for ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) is MQB.
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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.