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510(k) K811758

ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR by Powers Medical Systmes — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1981
Date Received
June 22, 1981
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 Powers Medical Systmes

  • K802779 — LOAD SENTINEL II, TRANS. ELEC. NERVE (December 10, 1980)
  • K801022 — ULTRA-CHEK PACEMAKER MONITOR (June 17, 1980)

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