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510(k) K895375

MULTISPIRO by Medical Equipment Designs, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1989
Date Received
August 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

Other clearances by Medical Equipment Designs, Inc.

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  • 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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