FDA 510(k)

Fetal Doppler U8-25, U9-25

Numéro K : K252669 · 2026-01-08

DemandeurZhongshan Xiaolan Town Senlan Electronic Factory

Date de décision2026-01-08

Code produitKNG

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Zhongshan Xiaolan Town Senlan Electronic Factory. The 510(k) number is K252669.

When did Fetal Doppler U8-25, U9-25 receive FDA 510(k) clearance?

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

Who is the listed applicant for Fetal Doppler U8-25, U9-25?

The FDA 510(k) record lists Zhongshan Xiaolan Town Senlan Electronic Factory as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : KNG)

K242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,Ltd K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd.

Source officielle

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