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510(k) K892659

ELECTRODELCA by Oldelft Corp. of America — Product Code IZG

K892659 is an FDA 510(k) premarket notification submitted by Oldelft Corp. of America for the device "ELECTRODELCA". The FDA issued a decision of Substantially Equivalent on November 21, 1989. The device falls under product code IZG (System, X-Ray, Photofluorographic), a Class II device regulated under 21 CFR 892.1730. Oldelft Corp. of America has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1989
Date Received
April 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Photofluorographic
Device Class
Class II
Regulation Number
892.1730
Review Panel
RA
Submission Type

Other clearances by Oldelft Corp. of America

  • K980296 — OLDELFT DIGIDELCA (April 17, 1998)
  • K973219 — AMBER DU (October 8, 1997)
  • K946128 — SIMULIX-HP (May 12, 1995)
  • K950037 — N 800 HF (February 15, 1995)
  • K932848 — SIMULIX-MC CT EXTENSION (March 22, 1994)
  • K923584 — THERAPAX DXT 300 SERIES 3 (January 15, 1993)
  • K914784 — PAPILLION PROCTOSCOPE (June 5, 1992)
  • K912466 — OLDELFT SIMULIX-MC (June 28, 1991)

Other clearances for product code IZG

  • K960082 — DISCOGRAPHY KIT (March 21, 1996)
  • K960146 — G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (February 27, 1996)
  • K913436 — PXI PNEUMATIC COMPRESSION PADDLE (November 5, 1992)
  • K920393 — MU125M MOBILE X-RAY SYSTEM (April 6, 1992)
  • K910503 — DISCOGRAPHY KIT (October 7, 1991)
  • K903808 — AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (January 22, 1991)

FDA data resources