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510(k) K900404

VARICOSCREEN(TM) by Promedex, Inc. — Product Code KYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1990
Date Received
January 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2982
Review Panel
RA
Submission Type

Other clearances by Promedex, Inc.

  • K914407 — PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION) (December 31, 1991)
  • K905764 — SEMINOR (March 12, 1991)

Other clearances for product code KYA

  • K832989 — BREAST THERMAL ACTIVITY INDICATOR (January 17, 1984)
  • K823245 — THERMAX; THERMAX SYSTEM (November 16, 1982)
  • K821524 — CHIROPRATIC INFRA-RED CRYSTAL PAK (September 8, 1982)
  • K821049 — PARATHERM (April 29, 1982)