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510(k) K882032

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

K882032 is an FDA 510(k) premarket notification submitted by Mesa Medical, Inc. for the device "MODEL 90DX MULTITEST METER". The FDA issued a decision of Substantially Equivalent on August 11, 1988. 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
August 11, 1988
Date Received
May 16, 1988
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.

  • K925210 — 90DX MULTITEST METER, MODIFICATION (January 25, 1994)
  • 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)
  • K925210 — 90DX MULTITEST METER, MODIFICATION (January 25, 1994)
  • 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