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510(k) K882327

PACER SENSING ANALYZER (PSA 100) by Oscor Medical Corp. — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1988
Date Received
June 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
Review Panel
CV
Submission Type

Other clearances by Oscor Medical Corp.

  • K964107 — OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR (April 1, 1997)
  • K925168 — MISCELLANEOUS PACING LEAD (May 3, 1994)
  • K923621 — EXTERNAL DEMAND PACEMAKER (May 19, 1993)
  • K912867 — OSCOR MEDICAL CORP PERMANENT PACING LEAD (February 4, 1992)
  • K915007 — PERMANENT PACING LEADS, MODIFICATION (January 27, 1992)
  • K915008 — PERMANENT PACING PAD, MODIFICATION (January 27, 1992)
  • K913201 — PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION (September 23, 1991)
  • K913202 — IMPLANT PACING LEAD, TINED #3262, MODIFICATION (September 23, 1991)
  • K913204 — MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION (September 23, 1991)
  • K913203 — IMPLANT PACING LEAD TINED #3390, MODIFICATION (September 23, 1991)

Other clearances for product code DTC

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  • K083674 — PK-141 PATIENT CABLE (April 1, 2009)
  • K011729 — SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 (August 30, 2001)
  • K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER (October 10, 2000)
  • K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (November 8, 1996)
  • K903966 — EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 (June 19, 1991)
  • K910595 — MODEL 5311B A-V PACING SYSTEM ANALYZER (May 7, 1991)
  • K910223 — CPI MODEL 2215/SEAMED MODEL 3400 (March 19, 1991)
  • K901332 — PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (May 9, 1990)
  • K896632 — MEDTRONIC MODEL 5401B TEST CABLE (December 13, 1989)