The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Sono-vu Us(tm), Modification.
| Device ID | K921738 |
| 510k Number | K921738 |
| Device Name: | SONO-VU US(TM), MODIFICATION |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Contact | Marlene Wright |
| Correspondent | Marlene Wright E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-29 |
| Decision Date | 1992-04-27 |