FDA DeviceClass IINotable
FDA Recall: Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Mod
Description
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Hazard
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Remedy
34
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