The following data is part of a premarket notification filed by Pie Medical Equipment B.v. with the FDA for Hemisphere Multiplane Endorectal Probe.
| Device ID | K911043 |
| 510k Number | K911043 |
| Device Name: | HEMISPHERE MULTIPLANE ENDORECTAL PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1991-10-09 |