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510(k) K901332

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE by Biotronik, GmbH & Co. — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1990
Date Received
March 22, 1990
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

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  • K910609 — PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (August 28, 1991)
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  • K910608 — PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP (July 30, 1991)
  • K905087 — TRIOS 02 (May 7, 1991)
  • K903928 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP (October 16, 1990)

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  • 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)
  • K896632 — MEDTRONIC MODEL 5401B TEST CABLE (December 13, 1989)
  • K884331 — MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER (January 10, 1989)