The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for High Velocity Cw Doppler System.
| Device ID | K862841 |
| 510k Number | K862841 |
| Device Name: | HIGH VELOCITY CW DOPPLER SYSTEM |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | Robert Courtney |
| Correspondent | Robert Courtney BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-29 |
| Decision Date | 1986-11-10 |