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510(k) K863471

COLORADO MEDICAL MODEL PTC 1000 by Colorado Medical, Inc. — Product Code KXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1986
Date Received
September 9, 1986
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

Other clearances by Colorado Medical, Inc.

  • K870689 — HR-3000 REUSE ADAPTOR (April 10, 1987)
  • K870471 — MODIFIED HR-3000 REUSE ADAPTOR (April 10, 1987)
  • K853735 — COLORADO MEDICAL MODEL CTM-3000 (October 4, 1985)
  • K841153 — ADAPTOR HR-3000 REUSE (July 16, 1984)
  • K830190 — AHR-3000 RE-USE ADAPTOR (May 27, 1983)

Other clearances for product code KXM

  • K925581 — BAXTER BIOSTAT 1000 UREA MONITOR (May 3, 1995)
  • K853536 — VELCRO FISTULA PRESSURE CLAMPS (October 17, 1985)
  • K831402 — PRESSURE MONITOR & CONTROL UNIT APC-02A (August 8, 1983)