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510(k) K770005

PACEMAKER 208S by Elema-Schonander, Inc. — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1977
Date Received
January 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Pacemaker Pulse-Generator
Device Class
Class III
Regulation Number
870.3610
Review Panel
CV
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)
  • K842903 — SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (August 21, 1984)
  • K842911 — PUCK U & UD CUTFILM CHANGERS (August 21, 1984)
  • K840389 — SEP PROGRAMMER SEP-M/SINGLE-PLANE & (February 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)
  • K770135 — LEAD MODIFICATION (February 7, 1977)

Other clearances for product code DXY

  • K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (November 10, 1999)
  • K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS (August 29, 1997)
  • K945627 — PIKOS LP 01, PIKOS LP E01 (March 4, 1996)
  • K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (December 15, 1995)
  • K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (December 15, 1995)
  • K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (September 29, 1995)
  • K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (September 29, 1995)
  • K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (September 1, 1995)
  • K940039 — PELLETHANE 75D (July 12, 1995)
  • K950751 — TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES (May 15, 1995)