The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Doppler Option For Platinum.
| Device ID | K900002 |
| 510k Number | K900002 |
| Device Name: | DOPPLER OPTION FOR PLATINUM |
| Classification | Echocardiograph |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 2722 SOUTH FAIRVIEW ST. Santa Ana, CA 92704 |
| Contact | Gladys D May |
| Correspondent | Gladys D May PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 2722 SOUTH FAIRVIEW ST. Santa Ana, CA 92704 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-02 |
| Decision Date | 1990-04-02 |