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FDA 510(k)

SKYTRON ELITE 3500 TABLE

K-Number: K940616 · 1994-06-13

ApplicantSkytron, Div. the Kmw Group, Inc.
Decision Date1994-06-13
Product CodeGDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKYTRON ELITE 3500 TABLE is the device name listed in this FDA 510(k) record. The listed applicant is Skytron, Div. the Kmw Group, Inc.. It received FDA 510(k) clearance on 1994-06-13 under 510(k) number K940616. 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 SKYTRON ELITE 3500 TABLE?

SKYTRON ELITE 3500 TABLE is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Skytron, Div. the Kmw Group, Inc.. The 510(k) number is K940616.

When did SKYTRON ELITE 3500 TABLE receive FDA 510(k) clearance?

SKYTRON ELITE 3500 TABLE received FDA 510(k) clearance on 1994-06-13, under 510(k) number K940616.

Who is the listed applicant for SKYTRON ELITE 3500 TABLE?

The FDA 510(k) record lists Skytron, Div. the Kmw Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKYTRON ELITE 3500 TABLE?

The FDA product code for SKYTRON ELITE 3500 TABLE is GDC.

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Other records listing Skytron, Div. the Kmw Group, 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.

K071698AURORA LED SERIES SURGICAL LIGHTSK021585STELLAR SERIES SURGICAL LIGHTS WITH HERMESK002463STELLARK992090MILLENNIUM GOLDK950192SKYTRON SKYBOOM SERIESK933564SKYTRON EXAM LIGHT

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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 AGK964273DURA-BOARD ARMBOARDAllen Medical Systems, 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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