AMICI XENON ADMINISTRATION SET— 510(k) K903805

Substantially Equivalent

Amici, Inc.

FDA 510(k) clearance K903805 for AMICI XENON ADMINISTRATION SET, Substantially Equivalent on 1991-01-14. Applicant: Amici, Inc.. Device class: 2.

Clearance details

Applicant: Amici, Inc.
Product code: Code IYT
Device class: Class 2
Regulation: 21 CFR 892.1390
Advisory panel: Radiology
Date received: 1990-08-15
Decision date: 1991-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spring City, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYT

K253942 — Pulmonex II Xenon System (132-503)2026-07-07
K200916 — Patient Administration Set2020-09-01
K953513 — XENON CIRCUIT1995-11-03
K952223 — XENON GAS BREATHING CIRCUIT1995-08-11
K914747 — XENON CIRCUIT1992-02-27

More clearances from Amici, Inc.

K063716 — AEROSOL SYSTEM2007-12-28
K952910 — THE SWIRLER NEBULIZER1997-03-19
K952893 — THE SWIRLER AEROSOL SYSTEM1995-11-03
K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION1991-01-14
K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE1990-10-03

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