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510(k) K910942

AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT by Mdt Biologic Co. — Product Code FSS

K910942 is an FDA 510(k) premarket notification submitted by Mdt Biologic Co. for the device "AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT". The FDA issued a decision of Substantially Equivalent on June 11, 1991. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Mdt Biologic Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1991
Date Received
March 6, 1991
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 Mdt Biologic Co.

  • K954736 — ACCESS (POWERCLAVE) (August 15, 1996)
  • K954940 — MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE (January 17, 1996)
  • K943654 — HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS (August 2, 1995)
  • K911087 — CASTLE WASHER/DISINFECTOR, MODEL 7550 (August 9, 1993)
  • K910777 — MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER (March 27, 1992)
  • K910778 — STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) (October 28, 1991)
  • K910649 — MDT/CASTLE 10/90 LOAD STATION (September 6, 1991)

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)
  • K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (August 18, 1998)
  • 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)

FDA data resources