DURA-BOARD ARMBOARD— 510(k) K964273

Name: FDA 510(k) clearance K964273
Creator: U.S. Food and Drug Administration
Published: 1997-01-08

Substantially Equivalent

Allen Medical Systems, Inc.

FDA 510(k) clearance K964273 for DURA-BOARD ARMBOARD, Substantially Equivalent on 1997-01-08. Applicant: Allen Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Allen Medical Systems, Inc.
Product code: Code GDC
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1996-10-28
Decision date: 1997-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDC

view all

K971390 — QUANTUM 3080SP SURGICAL TABLE1997-05-15
K970807 — MOBILE OPERATING TABLE 1132.011997-03-14
K940616 — SKYTRON ELITE 3500 TABLE1994-06-13
K934744 — MIDMARK MAGNUM GENERAL SURGICAL TABLE1994-03-28
K914758 — MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE1991-12-19

More clearances from Allen Medical Systems, Inc.

view all

K971988 — ALLEN, ULTRA AND SMART SOCKETS1997-07-11
K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER1996-03-12
K944779 — CARBON LIGHTS HAND SURGERY TABLE1994-10-14
K921168 — ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 20001993-04-21

Adverse events under product code GDC

product code GDC

Malfunction: 791
Total: 791

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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