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510(k) K821083

P.D. METER by Medical Equipment Designs, Inc. — Product Code HLH

K821083 is an FDA 510(k) premarket notification submitted by Medical Equipment Designs, Inc. for the device "P.D. METER". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code HLH (Pupillometer, Manual), a Class I device regulated under 21 CFR 886.1700. Medical Equipment Designs, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Medical Equipment Designs, Inc.

  • K911308 — CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE (September 11, 1991)
  • K894152 — MEDITHERM (June 11, 1990)
  • 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)
  • K821107 — EXOPHTHALMOMETER (June 14, 1982)
  • K821081 — CHART PROJECTOR (June 14, 1982)
  • K821084 — UNIVERSAL TRIAL FRAMEE (June 14, 1982)
  • K821082 — TRIAL LENS SET (June 14, 1982)

Other clearances for product code HLH

  • K821082 — TRIAL LENS SET (June 14, 1982)

FDA data resources