ROTO REST; TRAUMA AND INTENSIVE CARE BED— 510(k) K905113

Name: FDA 510(k) clearance K905113
Creator: U.S. Food and Drug Administration
Published: 1990-11-26

Substantially Equivalent

Ethos Medical Products , Ltd.

FDA 510(k) clearance K905113 for ROTO REST; TRAUMA AND INTENSIVE CARE BED, Substantially Equivalent on 1990-11-26. Applicant: Ethos Medical Products , Ltd.. Device class: 2.

Clearance details

Applicant: Ethos Medical Products , Ltd.
Product code: Code IKZ
Device class: Class 2
Regulation: 21 CFR 890.5225
Advisory panel: Physical Medicine
Date received: 1990-11-13
Decision date: 1990-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athlone, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IKZ

view all

K972486 — PRESSUREGUARD IV1998-02-20
K972111 — RUMORS DYNAMIC AIR THERAPY UNIT1998-02-02
K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM1997-04-30
K954671 — THE FREEDOM BED1996-04-01
K950756 — PULMONEX DYNAMIC AIR THERAPY UNIT1995-05-30

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