BiDop 3 pocket Doppler labeling includes uncleared fetal indication
Koven Technology is recalling the BiDop 3 Pocket Doppler packaged with a fetal probe because the product labeling includes a fetal indication for use that is not cleared under its 510(k).
- Product
- Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector
- Category
- Medical Device
- Distribution
- Distributed nationwide