Home / 510(k) Clearances / K931197

510(k) K931197

MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT by Meddev International Corp. — Product Code KZF

K931197 is an FDA 510(k) premarket notification submitted by Meddev International Corp. for the device "MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT". The FDA issued a decision of Substantially Equivalent on September 23, 1993. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. Meddev International Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1993
Date Received
March 9, 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 Meddev International Corp.

  • K940284 — MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION (February 28, 1994)
  • K874562 — SECURATRODE (January 28, 1988)
  • K771435 — URINARY LEG BAG, STEOILE (September 20, 1977)

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)
  • K932719 — RITTER MODEL 158 AND 159 EXAM LIGHTS (December 2, 1993)

FDA data resources