AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)— 510(k) K896031

Name: FDA 510(k) clearance K896031
Creator: U.S. Food and Drug Administration
Published: 1990-01-12

Substantially Equivalent

Concord/Portex

FDA 510(k) clearance K896031 for AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY), Substantially Equivalent on 1990-01-12. Applicant: Concord/Portex. Device class: 1.

Clearance details

Applicant: Concord/Portex
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1989-10-16
Decision date: 1990-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIO

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K960203 — G.E. STERILE AMNIOCENTESIS TRAY1996-03-14
K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY1996-03-12
K914419 — AMNIOTEST(TM)1993-09-01
K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE1992-11-05
K921738 — SONO-VU US(TM), MODIFICATION1992-04-27

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K924541 — EPIDURAL MINIPACK1993-07-09
K930286 — DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS1993-06-22
K923127 — NEEDLE-PRO CARTRIDGE1993-04-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.