Tenet Radiolucent Hand Table

Q: What is the product code of K963506?

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

FDA 510(k) K963506 · Tenet Medical Engineering

Substantially Equivalent

510(k) numberK963506

Submission

Device name: Tenet Radiolucent Hand Table
Applicant: Tenet Medical Engineering
Calgary, CA
Received: September 3, 1996
Decision date: January 9, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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

Other 510(k)s with product code FQO

510(k)	Device	Applicant	Decision
K240598	Maestro System (REF100)FQO · Traditional	Moon Surgical	06/03/2024SE
K221410	Maestro PlatformFQO · Traditional	Moon Surgical	12/02/2022SE
K090136	Steris Cmax XLT Surgical TableFQO · Traditional	STERIS Corporation	03/20/2009SE
K972810	OPT80 the Transportable (OPT80)FQO · Traditional	O.P.T. USA, Inc.	08/26/1997SE
K971988	Allen, Ultra and Smart SocketsFQO · Traditional	Allen Medical Systems, Inc.	07/11/1997SE
K971307	Amsco Surgical TableFQO · Traditional	STERIS Corporation	06/27/1997SE
K961886	Drager Gemina Wall-Mounted WorkplaceFQO · Traditional	Alm Surgical Equipment, Inc.	07/30/1996SE
K961742	Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemFQO · Traditional	Alm Surgical Equipment, Inc.	07/26/1996SE
K955750	TeletomFQO · Traditional	Berchtold Holding GmbH	02/08/1996SE
K953980	Kreuzer Ceiling Mounted Support Systems, KlinoportFQO · Traditional	Kreuzer Corp.	11/16/1995SE

More from Kreuzer Corp.

510(k)	Device	Decision
K963505	Tenet Mlti-Positioning Surgical Stirrup SystemHHP · Traditional	02/14/1997SE
K964102	Tenet Tibial Fracture SupportGBB · Traditional	12/05/1996SE

Questions and answers

When was Tenet Radiolucent Hand Table cleared by the FDA?

Tenet Radiolucent Hand Table (K963506) received a 510(k) decision of Substantially Equivalent on January 9, 1997, 128 days after the submission was received.

What is the product code of K963506?

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