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510(k) K925581

BAXTER BIOSTAT 1000 UREA MONITOR by Baxter Healthcare Corp — Product Code KXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
November 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System Accessories, Extracorporeal
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code KXM

  • K863471 — COLORADO MEDICAL MODEL PTC 1000 (October 2, 1986)
  • K853536 — VELCRO FISTULA PRESSURE CLAMPS (October 17, 1985)
  • K831402 — PRESSURE MONITOR & CONTROL UNIT APC-02A (August 8, 1983)