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510(k) K822316

HEART MONITOR BRACELET ALARM by Hmba — Product Code DRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1982
Date Received
August 3, 1982
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

Other clearances for product code DRI

  • K902493 — CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR (July 6, 1990)
  • K902492 — CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S (July 6, 1990)
  • K802326 — PRESSURE MONITORING LINES (October 10, 1980)