510(k) Report

Devices descending from K994008

6 later devices reach Biosys Fetal Monitor, Model Ifm-500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110612FM20Mediana Co., Ltd.20110—
+1K103545BT-350Bistos Co., Ltd.20110—
+1K052190Fetal Monitor, Models BT-300 and BT-200Bistos Co., Ltd.20053—
+2K110630F10Mediana Co., Ltd.20110—
+2K100885Fetal Monitor Model: BT-200TBistos Co., Ltd.20101—
+3K142799Model BT-220L and BT-220CBistos Co., Ltd.20150—