IV ARMBOARDS— 510(k) K781233

Substantially Equivalent

Fibre Formations, Inc.

FDA 510(k) clearance K781233 for IV ARMBOARDS, Substantially Equivalent on 1978-08-14. Applicant: Fibre Formations, Inc.. Device class: 1.

Clearance details

Applicant: Fibre Formations, Inc.
Product code: Code BTX
Device class: Class 1
Regulation: 21 CFR 878.3910
Advisory panel: General, Plastic Surgery
Date received: 1978-07-19
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTX

K935098 — BABY BOARD1994-02-15
K900175 — 4/1 ARMBOARD1990-01-24
K884838 — ALLEN PRONE ARMBOARD1988-12-15
K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD1988-07-08
K881292 — ALLEN LATERAL ARMBOARD1988-04-07

More clearances from Fibre Formations, Inc.

K791709 — HEEL/ELBOW PROTECTORS1979-09-24
K790922 — DISPOSABLE ADULT DIAPER1979-07-30
K781930 — PANT LINER, DISP. INCONTINENT1979-02-01
K781246 — FOAM COMFORT RINGS1978-08-10

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