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510(k) K821082

TRIAL LENS SET by Medical Equipment Designs, Inc. — Product Code HLH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
April 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pupillometer, Manual
Device Class
Class I
Regulation Number
886.1700
Review Panel
OP
Submission Type

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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)

Other clearances for product code HLH

  • K821083 — P.D. METER (June 14, 1982)