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FDA 510(k) Applications for Medical Device Product Code "HEK"
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| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K142769 | iCare Newlife Technologies, Inc. | Fetal Doppler | 03/20/2015 |
| K060410 | SUMMIT DOPPLER SYSTEMS, INC. | ECHOHEART TRANSVAGINAL DOPPLER PROBE | 04/10/2006 |