The following data is part of a premarket notification filed by Pie Medical Usa Bv with the FDA for Extended Multipurpose Transducer Range.
| Device ID | K880580 |
| 510k Number | K880580 |
| Device Name: | EXTENDED MULTIPURPOSE TRANSDUCER RANGE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PIE MEDICAL USA BV 3535 ROUTE 66 PARKWAY 100 Neptune Township, NJ 07753 |
| Contact | Riker |
| Correspondent | Riker PIE MEDICAL USA BV 3535 ROUTE 66 PARKWAY 100 Neptune Township, NJ 07753 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-10 |
| Decision Date | 1988-06-08 |