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510(k) K862668

HEALTHPHONE(TM) by Carelink — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1986
Date Received
July 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by Carelink

  • K874631 — HEALTHPHONE TOCO MODEL (March 11, 1988)

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