510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K994008Substantially Equivalent

Biosys Fetal Monitor, Model Ifm-500

Biosys Co., Ltd., San Leandro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994008 is the FDA 510(k) clearance record for BIOSYS FETAL MONITOR, MODEL IFM-500, a class II device, cleared for Biosys Co. , Ltd. on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list one 510(k) clearance for Biosys Co. , Ltd. As of , FDA records show no recalls naming K994008.

Clearance record

Decision date
Received
(310 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Biosys Co. , Ltd. 16303 Panoramic Way, San Leandro CA
510(k) summary
Summary
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