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FDA 510(k)

DURA-BOARD ARMBOARD

K-Number: K964273 · 1997-01-08

ApplicantAllen Medical Systems, Inc.
Decision Date1997-01-08
Product CodeGDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DURA-BOARD ARMBOARD is the device name listed in this FDA 510(k) record. The listed applicant is Allen Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-01-08 under 510(k) number K964273. The device is classified under product code GDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURA-BOARD ARMBOARD?

DURA-BOARD ARMBOARD is a medical device that received FDA 510(k) clearance on 1997-01-08. The listed applicant is Allen Medical Systems, Inc.. The 510(k) number is K964273.

When did DURA-BOARD ARMBOARD receive FDA 510(k) clearance?

DURA-BOARD ARMBOARD received FDA 510(k) clearance on 1997-01-08, under 510(k) number K964273.

Who is the listed applicant for DURA-BOARD ARMBOARD?

The FDA 510(k) record lists Allen Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURA-BOARD ARMBOARD?

The FDA product code for DURA-BOARD ARMBOARD is GDC.

Related Clinical Trials

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Other records listing Allen Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971988ALLEN, ULTRA AND SMART SOCKETSK960027HIGH VOLUME I.V. & IRRIGATION TOWERK944779CARBON LIGHTS HAND SURGERY TABLEK921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000

Related Devices (Code: GDC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971390QUANTUM 3080SP SURGICAL TABLESTERIS CorporationK970807MOBILE OPERATING TABLE 1132.01Stierlen-Maquet AGK940616SKYTRON ELITE 3500 TABLESkytron, Div. the Kmw Group, Inc.K934744MIDMARK MAGNUM GENERAL SURGICAL TABLEMidmark Corp.K914758MDT/SHAMPAINE MODEL 4900B SURGICAL TABLEMdt Corp., Inc.K915393MDT/SHAMPAINE MODEL 4900E SURGICAL TABLEMdt Corp., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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