The following data is part of a premarket notification filed by Pie Data Medical Bv with the FDA for Pie Medical Scanner 1000.
| Device ID | K870058 |
| 510k Number | K870058 |
| Device Name: | PIE MEDICAL SCANNER 1000 |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | PIE DATA MEDICAL BV PHILIPSWEG 1 Maastricht 6227 Aj, NL |
| Contact | Rikers |
| Correspondent | Rikers PIE DATA MEDICAL BV PHILIPSWEG 1 Maastricht 6227 Aj, NL |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-07 |
| Decision Date | 1988-02-02 |