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510(k) K821080

HAND KERATOSCOPE by Medical Equipment Designs, Inc. — Product Code HLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1982
Date Received
April 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Battery-Powered
Device Class
Class I
Regulation Number
886.1350
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)
  • 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 HLR

  • K901553 — SURG-K SURGICAL KERATOMETER (July 20, 1990)
  • K882902 — QRK 100, QUALITATIVE RING KERATOSCOPE (August 4, 1988)
  • K882618 — JEDMED/POLACK KERATOSCOPE HS/SL (July 13, 1988)
  • K864639 — REUSABLE SURGICAL KERATOSCOPE (December 29, 1986)
  • K854054 — PLACIDO DISC (December 27, 1985)
  • K830008 — KARICKHOFF KERATOSCOPE (January 26, 1983)