510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K123335Substantially Equivalent

Sunray Fetal Monitor

Sunray Medical Apparatus Co., Ltd., Shenzhen, Guangdong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123335 is the FDA 510(k) clearance record for SUNRAY FETAL MONITOR, a class II device, cleared for Sunray Medical Apparatus Co., Ltd. on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list one 510(k) clearance for Sunray Medical Apparatus Co., Ltd. As of , FDA records show no recalls naming K123335.

Clearance record

Decision date
Received
(146 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sunray Medical Apparatus Co., Ltd. B102 Nanshan Medical Devices, Shenzhen, Guangdong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HGM

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