LAKEVILLE BODY VENTILATOR— 510(k) K840885

Name: FDA 510(k) clearance K840885
Creator: U.S. Food and Drug Administration
Published: 1984-07-12

Substantially Equivalent

Edwards Ventilator Co.

FDA 510(k) clearance K840885 for LAKEVILLE BODY VENTILATOR, Substantially Equivalent on 1984-07-12. Applicant: Edwards Ventilator Co.. Device class: 2.

Clearance details

Applicant: Edwards Ventilator Co.
Product code: Code BYT
Device class: Class 2
Regulation: 21 CFR 868.5935
Advisory panel: Anesthesiology
Date received: 1984-02-27
Decision date: 1984-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYT

view all

K082657 — RTX RESPIRATOR2008-10-08
K072290 — PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS2008-05-29
K924341 — HAYEK OSCILLATOR(TM)1993-07-21
K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR1991-06-03
K905530 — PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM1991-03-01

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