The following data is part of a premarket notification filed by Pie Data Medical Bv with the FDA for Enterscan.
| Device ID | K874081 |
| 510k Number | K874081 |
| Device Name: | ENTERSCAN |
| Classification | Ultrasound, Sinus |
| Applicant | PIE DATA MEDICAL BV PHILIPSWEG 1 Maastricht 6227 Aj, NL |
| Contact | P. J Rikers |
| Correspondent | P. J Rikers PIE DATA MEDICAL BV PHILIPSWEG 1 Maastricht 6227 Aj, NL |
| Product Code | LWI |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-07 |
| Decision Date | 1987-12-31 |