HIO — Sampler, Amniotic Fluid (Amniocentesis Tray) Class I
FDA Device Classification
Classification Details
- Product Code
- HIO
- Device Class
- Class I
- Regulation Number
- 884.1550
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K960203 | ge medical systems | G.E. STERILE AMNIOCENTESIS TRAY | March 14, 1996 |
| K955679 | contour fabricators of florida | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | March 12, 1996 |
| K914419 | pro-lab | AMNIOTEST(TM) | September 1, 1993 |
| K922960 | cameo | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE | November 5, 1992 |
| K921738 | e-z-em | SONO-VU US(TM), MODIFICATION | April 27, 1992 |
| K915863 | mega medical | MEGA AMNIOCENTESIS KIT | March 30, 1992 |
| K904583 | e-z-em | SONO-VU US(TM) | June 24, 1991 |
| K901643 | healthdyne cardiovascular | ISOFLO(TM) AMNIOCENTESIS TRAY | July 25, 1990 |
| K900021 | e-z-em | PERCU-SET(TM) | March 29, 1990 |
| K896031 | concord/portex | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) | January 12, 1990 |
| K894031 | baxter healthcare | PHARMASEAL GENETIC AMNIOCENTESIS TRAY | August 4, 1989 |
| K892846 | cook ob/gyn | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE | July 14, 1989 |
| K890463 | critical specialties | ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY | April 7, 1989 |
| K862365 | swemed laboratories | NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE | July 7, 1986 |
| K854725 | bd becton dickinson vacutainer systems preanalytic | HURWITZ AMNIOCENTESIS NEEDLE | March 17, 1986 |
| K850632 | professional medical services | PMS AMNIOCENTESIS TRAY/KIT | May 22, 1985 |
| K844558 | universal medical instrument | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | January 31, 1985 |
| K830019 | universal medical instrument | AMNIO CENTESES KIT W/NEEDLE | January 18, 1983 |
| K802666 | aptek | APTEK ULTRASOUND PROCEDURE TRAY | November 26, 1980 |
| K761230 | pharmaseal div., baxter healthcare | AMMOCENTESIS TRAY (KIT) | December 17, 1976 |