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510(k) K911308

CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE by Medical Equipment Designs, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1991
Date Received
March 22, 1991
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 Medical Equipment Designs, Inc.

  • K894152 — MEDITHERM (June 11, 1990)
  • K895375 — MULTISPIRO (November 27, 1989)
  • K851277 — MICROSPIRO-SDS (April 19, 1985)
  • K840929 — FRC 85 SERIES SPIROMETER (May 14, 1984)
  • K840908 — CHESTAC-25F SPIROMETER (May 14, 1984)
  • K821084 — UNIVERSAL TRIAL FRAMEE (June 14, 1982)
  • K821081 — CHART PROJECTOR (June 14, 1982)
  • K821107 — EXOPHTHALMOMETER (June 14, 1982)
  • K821083 — P.D. METER (June 14, 1982)
  • K821082 — TRIAL LENS SET (June 14, 1982)

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