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510(k) K925210

90DX MULTITEST METER, MODIFICATION by Mesa Medical, Inc. — Product Code FLB

K925210 is an FDA 510(k) premarket notification submitted by Mesa Medical, Inc. for the device "90DX MULTITEST METER, MODIFICATION". The FDA issued a decision of Substantially Equivalent on January 25, 1994. The device falls under product code FLB (Meter, Conductivity, Induction, Remote Type), a Class II device regulated under 21 CFR 876.5820. Mesa Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1994
Date Received
October 7, 1992
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 by Mesa Medical, Inc.

  • K882032 — MODEL 90DX MULTITEST METER (August 11, 1988)
  • K870811 — MODEL 102 PH METER (March 24, 1987)
  • K852749 — RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT (September 10, 1985)
  • K843520 — WAREXIN RECOMMENDED ALTERNATIVE DIALYZ (October 4, 1984)
  • K834447 — ECHO MM1000 (March 23, 1984)
  • K821383 — ECHO, MODEL MM-1000 (June 23, 1982)

Other clearances for product code FLB

  • K100237 — DIALYSATE METER, MODEL D-6 (April 23, 2010)
  • 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)

FDA data resources