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510(k) K943342

MEDICAM XENON LIGHT SOURCE by M.P. Video, Inc. — Product Code FSW

K943342 is an FDA 510(k) premarket notification submitted by M.P. Video, Inc. for the device "MEDICAM XENON LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on October 17, 1994. The device falls under product code FSW (Light, Surgical, Endoscopic), a Class II device regulated under 21 CFR 878.4580. M.P. Video, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1994
Date Received
July 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Endoscopic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by M.P. Video, Inc.

  • K951386 — COMBINATION CAMERA/LIGHT SOURCE (June 30, 1995)
  • K942358 — AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERA (August 8, 1994)
  • K941773 — MEDICAM 900 REMOTE (July 18, 1994)
  • K941693 — MEDICAM ENDOCOUPLER AND BEAMSPLITTER (June 27, 1994)
  • K893828 — ML-800 AUTOELECTRONIC LIGHT SOURCE (July 24, 1989)
  • K882924 — MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS (July 26, 1988)
  • K871595 — SURGICAL CAMERA ACCESSORIES (May 7, 1987)
  • K871057 — MC-SERIES SURGICAL CAMERAS (April 3, 1987)
  • K871056 — MEDICAM S-4 SURGICAL CAMERA (March 31, 1987)
  • K820829 — MEDICAM (May 3, 1982)

Other clearances for product code FSW

  • K022989 — RADLITE TISSUE RETRACTOR SYSTEM (November 25, 2002)
  • K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (February 1, 2002)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)
  • K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT (September 2, 1992)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K894319 — MEDICAL DYNAMICS LIGHT SOURCE (October 3, 1989)
  • K870898 — ULTRA-LUX LIGHT SOURCE (March 18, 1987)

FDA data resources