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510(k) K932719

RITTER MODEL 158 AND 159 EXAM LIGHTS by Midmark Corp. — Product Code KZF

K932719 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "RITTER MODEL 158 AND 159 EXAM LIGHTS". The FDA issued a decision of Substantially Equivalent on December 2, 1993. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1993
Date Received
June 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Medical Examination, Ac Powered
Device Class
Class I
Regulation Number
880.6320
Review Panel
HO
Submission Type

Other clearances by Midmark Corp.

  • K122643 — VANTAGE MODEL V5000, V5100, V5000C, V5100C (January 7, 2013)
  • K120239 — ELEVANCE (August 24, 2012)
  • K112380 — CLEARVISION (November 22, 2011)
  • K091866 — PROGENY VANTAGE PANORAMIC X-RAY SYSTEM (July 20, 2009)
  • K090670 — MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER (July 7, 2009)
  • K023348 — MIDMARK M9 ULTRACLAVE STEAM STERILIZER (March 3, 2003)
  • K003090 — MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM (October 18, 2000)
  • K992744 — MIDMARK M4*9 EASYCLAVE STEAM STERILIZER (January 10, 2000)
  • K990189 — MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (April 19, 1999)
  • K936181 — MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (November 30, 1994)

Other clearances for product code KZF

  • K954943 — NEVOSCOPE (March 27, 1996)
  • K952835 — WELCH ALLYN VIDEO EPISCOPE (September 22, 1995)
  • K945507 — H 5100, H 5200, H 5300 (December 9, 1994)
  • K941869 — SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG (August 3, 1994)
  • K936088 — WAVE FLUORESCENT MAGNIFIER (April 26, 1994)
  • K940284 — MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION (February 28, 1994)
  • K933564 — SKYTRON EXAM LIGHT (February 10, 1994)
  • K935832 — CHROMOPHARE (February 3, 1994)
  • K934259 — AC-POWERED MEDICAL EXAMINATION LIGHT (January 28, 1994)
  • K924447 — VITAPEN (September 27, 1993)

FDA data resources