ALLEN PRONE ARMBOARD— 510(k) K884838

Name: FDA 510(k) clearance K884838
Creator: U.S. Food and Drug Administration
Published: 1988-12-15

Substantially Equivalent

Edgewater Medical Systems, Inc.

FDA 510(k) clearance K884838 for ALLEN PRONE ARMBOARD, Substantially Equivalent on 1988-12-15. Applicant: Edgewater Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Edgewater Medical Systems, Inc.
Product code: Code BTX
Device class: Class 1
Regulation: 21 CFR 878.3910
Advisory panel: General, Plastic Surgery
Date received: 1988-11-21
Decision date: 1988-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mayfield Hts., OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTX

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K935098 — BABY BOARD1994-02-15
K900175 — 4/1 ARMBOARD1990-01-24
K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD1988-07-08
K881292 — ALLEN LATERAL ARMBOARD1988-04-07
K864670 — BOARD, ARM (WITH COVER)1987-01-12

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