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510(k) K944257

LIONHEART 3 MULTI-PARAMETER SIMULATOR by Bio-Tek Instruments, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1994
Date Received
August 31, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Bio-Tek Instruments, Inc.

  • K973609 — IDA-4 AND IPT-MC (December 18, 1997)
  • K971273 — INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF (October 8, 1997)
  • K961862 — MODELS IDA-2 PLUS AND IPT-1 (February 26, 1997)
  • 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)
  • K933519 — INDEX SPO2 SIMULATOR (September 1, 1994)
  • K933548 — ELS 1000 (October 29, 1993)

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