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510(k) K822316

HEART MONITOR BRACELET ALARM by Hmba — Product Code DRI

K822316 is an FDA 510(k) premarket notification submitted by Hmba for the device "HEART MONITOR BRACELET ALARM". The FDA issued a decision of Substantially Equivalent on September 21, 1982. The device falls under product code DRI (Monitor, Line Isolation), a Class I device regulated under 21 CFR 870.2620.

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

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

FDA data resources