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FDA 510(k)

Fetal Doppler U8-25, U9-25

K-Number: K252669 · 2026-01-08

Decision Date2026-01-08
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fetal Doppler U8-25, U9-25 is a medical device manufactured by Zhongshan Xiaolan Town Senlan Electronic Factory. It received FDA 510(k) clearance on 2026-01-08 under approval number K252669. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fetal Doppler U8-25, U9-25?

Fetal Doppler U8-25, U9-25 is a medical device that received FDA 510(k) clearance on 2026-01-08. It is manufactured by Zhongshan Xiaolan Town Senlan Electronic Factory. The 510(k) number is K252669.

When was Fetal Doppler U8-25, U9-25 approved by the FDA?

Fetal Doppler U8-25, U9-25 received FDA 510(k) clearance on 2026-01-08, under approval number K252669.

What company makes Fetal Doppler U8-25, U9-25?

Fetal Doppler U8-25, U9-25 is manufactured by Zhongshan Xiaolan Town Senlan Electronic Factory.

What is the FDA product code for Fetal Doppler U8-25, U9-25?

The FDA product code for Fetal Doppler U8-25, U9-25 is KNG.

Related Clinical Trials

Related Devices (Code: KNG)

Official Source

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