The following data is part of a premarket notification filed by Pie Data Medical Bv with the FDA for Fetal Care Monitor Antepartum 1500.
| Device ID | K871082 |
| 510k Number | K871082 |
| Device Name: | FETAL CARE MONITOR ANTEPARTUM 1500 |
| Classification | System, Monitoring, Perinatal |
| 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 | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-18 |
| Decision Date | 1987-08-04 |