The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Sono-vu Us(tm).
| Device ID | K904583 |
| 510k Number | K904583 |
| Device Name: | SONO-VU US(TM) |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | E-Z-EM, INC. 373 PLANTATION ST. Worcester, MA 01605 |
| Contact | Georganne Brown |
| Correspondent | Georganne Brown E-Z-EM, INC. 373 PLANTATION ST. Worcester, MA 01605 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-09 |
| Decision Date | 1991-06-24 |