The following data is part of a premarket notification filed by Acuson Corp. with the FDA for L582 Transducer.
| Device ID | K904600 |
| 510k Number | K904600 |
| Device Name: | L582 TRANSDUCER |
| Classification | Monitor, Fetal Doppler Ultrasound |
| Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| Contact | W Pickering |
| Correspondent | W Pickering ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| Product Code | MAA |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-10 |
| Decision Date | 1991-06-24 |