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510(k) K812613

VIDICAM 200 by Diversified P.A. — Product Code IZJ

K812613 is an FDA 510(k) premarket notification submitted by Diversified P.A. for the device "VIDICAM 200". The FDA issued a decision of Substantially Equivalent on December 8, 1981. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620. Diversified P.A. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1981
Date Received
September 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, X-Ray, Fluorographic, Cine Or Spot
Device Class
Class II
Regulation Number
892.1620
Review Panel
RA
Submission Type

Other clearances by Diversified P.A.

  • K820571 — XENAMATIC SERIES OF XENON REBREATH DEV (March 31, 1982)

Other clearances for product code IZJ

  • K024085 — CCD CAMERA, MODEL PKP-06000-000 (March 11, 2003)
  • K972130 — DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSAB (October 9, 1997)
  • K945580 — DSP OPTION (January 30, 1995)
  • K920793 — PHILIPS DSI SYSTEM RELEASE 3.2 (July 17, 1992)
  • K896615 — CINE CAMERA CONTROL MODEL PK2037 (January 4, 1990)
  • K881688 — DTV-4114 FLUOROSCOPIC TELEVISION CAMERA (May 18, 1988)
  • K853983 — CANON X-RAY 35MM CINE CAMERA CSI-35 (October 16, 1985)
  • K810191 — SIRCAM 103 (February 26, 1981)
  • K810072 — 105MM ROLL FILM FLUOROGR. CAMERA, #105 (February 12, 1981)
  • K802132 — 105MM SPOT FILM CAMERA (October 23, 1980)

FDA data resources