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510(k) K903966

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 by Bio-Tek Instruments, Inc. — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1991
Date Received
August 28, 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

Other clearances by Bio-Tek Instruments, Inc.

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  • K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER (November 17, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)
  • K950104 — ELX800 AND EL800 AUTOMATED MICROPLATE READERS (March 21, 1995)
  • K942923 — CERES 900C & CERES UV900C (February 6, 1995)
  • K944257 — LIONHEART 3 MULTI-PARAMETER SIMULATOR (September 21, 1994)
  • K933519 — INDEX SPO2 SIMULATOR (September 1, 1994)

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  • K901332 — PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (May 9, 1990)
  • K896632 — MEDTRONIC MODEL 5401B TEST CABLE (December 13, 1989)
  • K884331 — MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER (January 10, 1989)