Kinetic Model 132

FDA 510(k) K891758 · Kinetic Biomedical Services, Inc.

Substantially Equivalent

510(k) numberK891758

Submission

Device name
Kinetic Model 132
Applicant
Kinetic Biomedical Services, Inc.
Erie, PA, US
Received
March 23, 1989
Decision date
April 19, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FSS – Light, Surgical, Floor Standing
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

Other 510(k)s with product code FSS

510(k)DeviceApplicantDecision
K091246Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)FSS · Abbreviated Trumpf Medizin Systeme GmbH + Co. KG09/28/2009SE
K003489Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…FSS · Traditional Medical Illumination International, Inc.02/02/2001SE
K984124Aesculap Xenon Light SourceFSS · Traditional Aesculap, Inc.02/01/1999SE
K981962Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional Cuda Products Co.08/18/1998SE
K981821Ves 3001/2 Dual Output Video IlluminatorFSS · Traditional Angiolaz, Inc.07/29/1998SE
K981469CERMAX300 LightsourceFSS · Traditional Cuda Products Co.07/09/1998SE
K980044Xenon 300MXFSS · Traditional Perkinelmer Optoelectronics04/03/1998SE
K970886Hanaulux Blue 80 HospitalFSS · Traditional Heraeus Med GmbH04/16/1997SE
K961971Q-5000FSS · Traditional Stryker Endoscopy06/28/1996SE
K961074Lightsource or IlluminatorFSS · Traditional Cuda Products Co.04/30/1996SE

More from Cuda Products Co.

510(k)DeviceDecision
K892808Kinetic Model 700FSY · Traditional 06/15/1989SE
K891759Kinetic Model 330FSS · Traditional 04/19/1989SE
K891757Kinetic Model 1000FSY · Traditional 04/19/1989SE
K891756Kinetic Model 500FSY · Traditional 04/19/1989SE

Questions and answers

When was Kinetic Model 132 cleared by the FDA?

Kinetic Model 132 (K891758) received a 510(k) decision of Substantially Equivalent on April 19, 1989, 27 days after the submission was received.

What is the product code of K891758?

The FDA product code is FSS – Light, Surgical, Floor Standing, a Class II (moderate risk) device regulated under 21 CFR 878.4580.