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510(k) K902493

CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR by Datex Division Instrumentarium Corp. — Product Code DRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1990
Date Received
June 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Line Isolation
Device Class
Class I
Regulation Number
870.2620
Review Panel
CV
Submission Type

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Other clearances for product code DRI

  • K902492 — CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S (July 6, 1990)
  • K822316 — HEART MONITOR BRACELET ALARM (September 21, 1982)
  • K802326 — PRESSURE MONITORING LINES (October 10, 1980)