The following data is part of a premarket notification filed by Pie Medical Equipment B.v. with the FDA for Transvaginal Transducer Assembly.
| Device ID | K900838 |
| 510k Number | K900838 |
| Device Name: | TRANSVAGINAL TRANSDUCER ASSEMBLY |
| Classification | Transducer, Ultrasonic, Obstetric |
| 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 | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-22 |
| Decision Date | 1990-05-23 |