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510(k) K843900

FOCUSCOPE UNIVERSAL SYSTEM by Medical Diagnostics, Ca. — Product Code GDB

K843900 is an FDA 510(k) premarket notification submitted by Medical Diagnostics, Ca. for the device "FOCUSCOPE UNIVERSAL SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 1984. The device falls under product code GDB (Endoscope, Fiber Optic), a Class II device regulated under 21 CFR 876.1500. Medical Diagnostics, Ca. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1984
Date Received
October 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Fiber Optic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Medical Diagnostics, Ca.

  • K853140 — MDI QUIK TEST NARCOTICS DRUG SCREEN (March 3, 1986)
  • K843343 — MEDICA IIF-ANTI-THYROID ANTIBODY TEST (October 22, 1984)
  • K831100 — MEDICA IIF-MULTIPLE ANTIBODY TEST KIT (May 4, 1983)

Other clearances for product code GDB

  • K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHT (August 20, 2003)
  • K961536 — FLEXSCOPE (September 18, 1996)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • K882061 — OLYMPUS GF-UM3/EU-M3 (November 15, 1988)
  • K855151 — FRITCH OPHTHALMIC ENDOSCOPE (February 19, 1986)
  • K810007 — PENTAX UPPER G.I. FIBERSCOPE, #FG-34 (January 15, 1981)

FDA data resources