Sono-Vu Us(Tm), Modification
FDA 510(k) K921738 · E-Z-Em, Inc.
510(k) numberK921738
Submission
- Device name
- Sono-Vu Us(Tm), Modification
- Applicant
- E-Z-Em, Inc.
Glens Falls, NY, US - Received
- January 29, 1992
- Decision date
- April 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIO – Sampler, Amniotic Fluid (Amniocentesis Tray)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.1550
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960203 | G.E. Sterile Amniocentesis TrayHIO · Traditional | GE Medical Systems | 03/14/1996SE |
| K955679 | RNS Sterile, Disposable Amniocentesis TrayHIO · Traditional | Contour Fabricators of Florida, Inc. | 03/12/1996SE |
| K914419 | Amniotest(Tm)HIO · Traditional | Pro-Lab, Inc. | 09/01/1993SE |
| K922960 | Various Cameo Med Amniocentesis Trays, DisposableHIO · Traditional | Cameo, Inc. | 11/05/1992SEKD |
| K915863 | Mega Amniocentesis KitHIO · Traditional | Mega Medical, Inc. | 03/30/1992SEKD |
| K904583 | Sono-Vu Us(Tm)HIO · Traditional | E-Z-Em, Inc. | 06/24/1991SE |
| K901643 | Isoflo(Tm) Amniocentesis TrayHIO · Traditional | Healthdyne Cardiovascular, Inc. | 07/25/1990SE |
| K900021 | Percu-Set(Tm)HIO · Traditional | E-Z-Em, Inc. | 03/29/1990SE |
| K896031 | Amniotic Fluid Sampler (Amniocentesis Tray)HIO · Traditional | Concord/Portex | 01/12/1990SE |
| K894031 | Pharmaseal Genetic Amniocentesis TrayHIO · Traditional | Baxter Healthcare Corp | 08/04/1989SESD |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K071378 | Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product SeriesJAK · Special | 06/13/2007SE |
| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | 04/13/2007SE |
| K063029 | Empower Ct/Cta Injector System, Model 9800/9900JAK · Special | 11/02/2006SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | 12/27/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | 07/16/2004SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | 06/19/2003SE |
| K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400FCX · Special | 04/16/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | 02/19/2002SE |
| K011160 | E-Z Em Percupump 2001 CT InjectorJAK · Special | 05/16/2001SE |
| K974621 | Percupump II with EdaDSB · Traditional | 01/27/1998SE |
Questions and answers
When was Sono-Vu Us(Tm), Modification cleared by the FDA?
Sono-Vu Us(Tm), Modification (K921738) received a 510(k) decision of Substantially Equivalent on April 27, 1992, 89 days after the submission was received.
What is the product code of K921738?
The FDA product code is HIO – Sampler, Amniotic Fluid (Amniocentesis Tray), a Class I (low risk) device regulated under 21 CFR 884.1550.