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510(k) K820599

AUTOSPIROMETER HI-498 by Medical Equipment Designs, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1982
Date Received
March 4, 1982
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)
  • 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)

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