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510(k) K894152

MEDITHERM by Medical Equipment Designs, Inc. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1990
Date Received
June 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by Medical Equipment Designs, Inc.

  • K911308 — CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE (September 11, 1991)
  • K895375 — MULTISPIRO (November 27, 1989)
  • K851277 — MICROSPIRO-SDS (April 19, 1985)
  • K840908 — CHESTAC-25F SPIROMETER (May 14, 1984)
  • K840929 — FRC 85 SERIES 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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