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510(k) K831638

SINGLE BED ARRHYTHMIA MONITOR AM500 by Lifeline Systems, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Lifeline Systems, Inc.

  • K103214 — M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 (December 1, 2010)
  • K914103 — LIFELINE(R) PERSONAL RESPONSE SYSTEM (September 27, 1991)
  • K834441 — BLOOD PRESSURE MONITOR BP600X (May 21, 1984)

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