Kinetic Model 700

FDA 510(k) K892808 · Kinetic Biomedical Services, Inc.

Substantially Equivalent

510(k) numberK892808

Submission

Device name
Kinetic Model 700
Applicant
Kinetic Biomedical Services, Inc.
Erie, PA, US
Received
April 17, 1989
Decision date
June 15, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FSY – Light, Surgical, Ceiling Mounted
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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K132551ZF 720FSY · Traditional Umbel Corporation06/30/2014SE
K140930Vida LED Surgical Lighting System, V SeriesFSY · Traditional Convida Healthcare & Systems Corporation06/09/2014SE
K140461Mach LED 2MCFSY · Special Dr. Mach GmbH & Co. KG04/03/2014SE
K140460Mach LED 2SCFSY · Special Dr. Mach GmbH & Co. KG04/03/2014SE
K132747Visum Blade LED Surgical Lighting SystemFSY · Traditional Stryker Communications12/30/2013SE
K132307Vida LED Surgical Lighting SystemFSY · Traditional Convida Healthcare & Systems Corporation11/05/2013SE
K131893Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical LightsFSY · Traditional Ajw Technology Consultants, Inc.10/30/2013SE

More from Ajw Technology Consultants, Inc.

510(k)DeviceDecision
K891759Kinetic Model 330FSS · Traditional 04/19/1989SE
K891758Kinetic Model 132FSS · 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 700 cleared by the FDA?

Kinetic Model 700 (K892808) received a 510(k) decision of Substantially Equivalent on June 15, 1989, 59 days after the submission was received.

What is the product code of K892808?

The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.