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FDA 510(k)

HnX-P1, HnX-PB

K-Number: K251223 · 2025-08-04

ApplicantH&abyz Co., Ltd.
Decision Date2025-08-04
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HnX-P1, HnX-PB is a medical device manufactured by H&abyz Co., Ltd.. It received FDA 510(k) clearance on 2025-08-04 under approval number K251223. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HnX-P1, HnX-PB?

HnX-P1, HnX-PB is a medical device that received FDA 510(k) clearance on 2025-08-04. It is manufactured by H&abyz Co., Ltd.. The 510(k) number is K251223.

When was HnX-P1, HnX-PB approved by the FDA?

HnX-P1, HnX-PB received FDA 510(k) clearance on 2025-08-04, under approval number K251223.

What company makes HnX-P1, HnX-PB?

HnX-P1, HnX-PB is manufactured by H&abyz Co., Ltd..

What is the FDA product code for HnX-P1, HnX-PB?

The FDA product code for HnX-P1, HnX-PB is IZL.

Other Devices by H&abyz Co., Ltd.

K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) K203188ADD K223930A1417MCW/A1717MCW/F1417MCW

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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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