DR7700 Operating Table

FDA 510(k) K864325 · Koken Mfg Company, Inc.

Substantially Equivalent

510(k) numberK864325

Submission

Device name
DR7700 Operating Table
Applicant
Koken Mfg Company, Inc.
St. Louis, MO, US
Received
November 3, 1986
Decision date
November 19, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FQO – Table, Operating-Room, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4960
Specialty
General, Plastic Surgery

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K972810OPT80 the Transportable (OPT80)FQO · Traditional O.P.T. USA, Inc.08/26/1997SE
K971988Allen, Ultra and Smart SocketsFQO · Traditional Allen Medical Systems, Inc.07/11/1997SE
K971307Amsco Surgical TableFQO · Traditional STERIS Corporation06/27/1997SE
K963506Tenet Radiolucent Hand TableFQO · Traditional Tenet Medical Engineering01/09/1997SE
K961886Drager Gemina Wall-Mounted WorkplaceFQO · Traditional Alm Surgical Equipment, Inc.07/30/1996SE
K961742Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemFQO · Traditional Alm Surgical Equipment, Inc.07/26/1996SE
K955750TeletomFQO · Traditional Berchtold Holding GmbH02/08/1996SE

More from Berchtold Holding GmbH

510(k)DeviceDecision
K864501Koken's New Model M-3000 Power Table · Traditional 12/16/1986SE
K864574Mac 150E Opthalmic ChairHME · Traditional 12/15/1986SE
K864494Model 6500 Opthalmic ChairHME · Traditional 12/15/1986SE
K864295DR.500O Operating TableFQO · Traditional 11/19/1986SE

Questions and answers

When was DR7700 Operating Table cleared by the FDA?

DR7700 Operating Table (K864325) received a 510(k) decision of Substantially Equivalent on November 19, 1986, 16 days after the submission was received.

What is the product code of K864325?

The FDA product code is FQO – Table, Operating-Room, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.