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510(k) K891757

KINETIC MODEL 1000 by Kinetic Biomedical Services, Inc. — Product Code FSY

K891757 is an FDA 510(k) premarket notification submitted by Kinetic Biomedical Services, Inc. for the device "KINETIC MODEL 1000". The FDA issued a decision of Substantially Equivalent on April 19, 1989. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Kinetic Biomedical Services, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1989
Date Received
March 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Kinetic Biomedical Services, Inc.

  • K892808 — KINETIC MODEL 700 (June 15, 1989)
  • K891756 — KINETIC MODEL 500 (April 19, 1989)
  • K891758 — KINETIC MODEL 132 (April 19, 1989)
  • K891759 — KINETIC MODEL 330 (April 19, 1989)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)

FDA data resources