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510(k) K840389

SEP PROGRAMMER SEP-M/SINGLE-PLANE & by Elema-Schonander, Inc. — Product Code IZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
January 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Changer, Film/Cassette, Radiographic
Device Class
Class II
Regulation Number
892.1870
Review Panel
RA
Submission Type

Other clearances by Elema-Schonander, Inc.

  • K934944 — MPQ-42 (December 15, 1993)
  • K904103 — SEP 90 (November 20, 1990)
  • K903576 — PUCK 90M (September 4, 1990)
  • K842911 — PUCK U & UD CUTFILM CHANGERS (August 21, 1984)
  • K842903 — SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (August 21, 1984)
  • K790792 — PULSE GENERATOR MODEL 637 (October 12, 1979)
  • K790670 — PULSE GENERATOR MODEL 629 (June 27, 1979)
  • K781178 — PULSE GENERATOR MODEL 208 (September 7, 1978)
  • K770005 — PACEMAKER 208S (February 24, 1977)
  • K770135 — LEAD MODIFICATION (February 7, 1977)

Other clearances for product code IZP

  • K934944 — MPQ-42 (December 15, 1993)
  • K911888 — PHILIPS ANGIOPRO (October 15, 1991)
  • K904144 — PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM (December 13, 1990)
  • K904103 — SEP 90 (November 20, 1990)
  • K874451 — OMNIPLANE 200 FILM CHANGER SYSTEM (February 11, 1988)
  • K854251 — THE CSE FILM CHANGER SYSTEM (October 28, 1985)
  • K842903 — SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (August 21, 1984)
  • K841732 — LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (June 5, 1984)
  • K841649 — MAXIMAX - 4 (June 5, 1984)