Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)

K-Number: K213497 · 2021-11-15

Decision Date2021-11-15
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) is the device name listed in this FDA 510(k) record. The listed applicant is H&abyz Co., Ltd.. It received FDA 510(k) clearance on 2021-11-15 under 510(k) 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. The listed applicant is H&abyz Co., Ltd.. The 510(k) number is K213497.

When did ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) receive FDA 510(k) clearance?

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) received FDA 510(k) clearance on 2021-11-15, under 510(k) number K213497.

Who is the listed applicant for ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)?

The FDA 510(k) record lists H&abyz Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing H&abyz Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.