510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100626Substantially Equivalent

Doppler Fetal Heart Rate Detector, Model Fm-200

Shenzhen Biocare Electronics Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100626 is the FDA 510(k) clearance record for DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200, a class II device, cleared for Shenzhen Biocare Electronics Co., Ltd. on under FDA product code KNG (Monitor, Ultrasonic, Fetal). FDA records list 5 510(k) clearances for Shenzhen Biocare Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K100626.

Clearance record

Decision date
Received
(77 days to decision)
Product code
KNG Monitor, Ultrasonic, Fetal
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Shenzhen Biocare Electronics Co., Ltd. Suite 5d, No 19, Ln. 999, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNG

Trailing 12 months
1 clearance under product code KNG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260