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510(k) K904113

OPERATIVE RECORDING CAMERA by Medical Dynamics, Inc. — Product Code IKO

K904113 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "OPERATIVE RECORDING CAMERA". The FDA issued a decision of Substantially Equivalent on October 30, 1990. The device falls under product code IKO (Hammer, Reflex, Powered), a Class II device regulated under 21 CFR 890.1450. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1990
Date Received
September 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hammer, Reflex, Powered
Device Class
Class II
Regulation Number
890.1450
Review Panel
PM
Submission Type

Other clearances by Medical Dynamics, Inc.

  • K974542 — TRUE VISION, TRUE VISION II (February 17, 1998)
  • K921294 — VIDEO ENDOSCOPE-RIGID MODIFICATION (July 20, 1994)
  • K934682 — SURGICAL VIDEO CAMERA AND ACCESSORIES (February 15, 1994)
  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • K915538 — OVER THE WIRE STONE BASKET (March 20, 1992)
  • K914315 — OPTICAL CATHETER INTRODUCER SETS, MODIFICATION (March 4, 1992)
  • K913986 — CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM (January 28, 1992)
  • K911296 — OPTICAL CATHETER ARTHROSCOPE (September 24, 1991)
  • K903339 — VIDEO ENDOSCOPE, RIGID (March 6, 1991)
  • K904609 — XENON LIGHT SOURCE (December 18, 1990)

FDA data resources