The following data is part of a premarket notification filed by Pie Medical Equipment B.v. with the FDA for Sc1150 Cw/pd.
| Device ID | K912819 |
| 510k Number | K912819 |
| Device Name: | SC1150 CW/PD |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PIE MEDICAL EQUIPMENT B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj |
| Contact | Rikers |
| Correspondent | Rikers PIE MEDICAL EQUIPMENT B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1992-01-09 |