The following data is part of a premarket notification filed by Pie Data Medical Bv with the FDA for Multipurpose Transducer Range.
Device ID | K874192 |
510k Number | K874192 |
Device Name: | MULTIPURPOSE TRANSDUCER RANGE |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
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 | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-14 |
Decision Date | 1988-07-19 |