The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Contiuous Wave Doppler Ultrasound.
| Device ID | K802670 |
| 510k Number | K802670 |
| Device Name: | CONTIUOUS WAVE DOPPLER ULTRASOUND |
| Classification | Echocardiograph |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-27 |
| Decision Date | 1980-11-26 |