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510(k) K903512

FUTURECARE CARELYNK IV SYSTEM by Futurecare Systems, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1991
Date Received
August 3, 1990
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 Futurecare Systems, Inc.

  • K871944 — FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) (June 24, 1987)
  • K863716 — RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER (December 22, 1986)

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