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FDA 510(k)

ADD

K-Number: K203188 · 2021-03-12

ApplicantH&abyz Co., Ltd.
Decision Date2021-03-12
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADD is a medical device manufactured by H&abyz Co., Ltd.. It received FDA 510(k) clearance on 2021-03-12 under approval number K203188. 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?

ADD is a medical device that received FDA 510(k) clearance on 2021-03-12. It is manufactured by H&abyz Co., Ltd.. The 510(k) number is K203188.

When was ADD approved by the FDA?

ADD received FDA 510(k) clearance on 2021-03-12, under approval number K203188.

What company makes ADD?

ADD is manufactured by H&abyz Co., Ltd..

What is the FDA product code for ADD?

The FDA product code for ADD is MQB.

Other Devices by H&abyz Co., Ltd.

K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) K223930A1417MCW/A1717MCW/F1417MCW K251223HnX-P1, HnX-PB

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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.

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