The following data is part of a premarket notification filed by Pie Medical Usa Bv with the FDA for Ultrasound Scanner Model #1150.
| Device ID | K900469 |
| 510k Number | K900469 |
| Device Name: | ULTRASOUND SCANNER MODEL #1150 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PIE MEDICAL USA BV 3535 ROUTE 66 PARKWAY 100 Neptune Township, NJ 07753 |
| Contact | Peter Rikers |
| Correspondent | Peter Rikers PIE MEDICAL USA BV 3535 ROUTE 66 PARKWAY 100 Neptune Township, NJ 07753 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-31 |
| Decision Date | 1990-07-09 |