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510(k) K100237

DIALYSATE METER, MODEL D-6 by Myron L Company — Product Code FLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2010
Date Received
January 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Conductivity, Induction, Remote Type
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances for product code FLB

  • K925210 — 90DX MULTITEST METER, MODIFICATION (January 25, 1994)
  • K882032 — MODEL 90DX MULTITEST METER (August 11, 1988)
  • K830629 — COBE RX METER (April 6, 1983)
  • K821415 — MODEL 90 BC (May 27, 1982)
  • K770263 — DIALYSATE METER RS-2100A, CIRCUIT CHANGE (February 18, 1977)