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510(k) K981962

CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE by Cuda Products Co. — Product Code FSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1998
Date Received
June 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Floor Standing
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Cuda Products Co.

  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • K981469 — CERMAX300 LIGHTSOURCE (July 9, 1998)
  • K980350 — VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 (April 28, 1998)
  • K980166 — LIGHTSOURCE OR ILLUMINATOR (April 1, 1998)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)
  • K951019 — INTRAORAL VIDEO SCOPE AND WINDOW TUBE (May 10, 1995)
  • K943731 — VIDEO OTOSCOPE (October 11, 1994)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • K933369 — CUDA PRODUCTS CORP. LIGHTSOURCES (January 3, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)

Other clearances for product code FSS

  • K091246 — ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M (September 28, 2009)
  • K003489 — NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT G (February 2, 2001)
  • K984124 — AESCULAP XENON LIGHT SOURCE (February 1, 1999)
  • K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (July 29, 1998)
  • K981469 — CERMAX300 LIGHTSOURCE (July 9, 1998)
  • K980044 — XENON 300MX (April 3, 1998)
  • K970886 — HANAULUX BLUE 80 HOSPITAL (April 16, 1997)
  • K961971 — Q-5000 (June 28, 1996)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)
  • K930711 — TRI*STAR (July 30, 1993)