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510(k) K831747

PLASMA THERAPY TUBESET-E100 SERIES by Parker Hannifin Corp. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
June 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K897086 — PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 (September 28, 1990)
  • K863532 — MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER (January 14, 1987)
  • K833723 — MODEL 2000 AMBULATORY MED. INFUSER (January 30, 1984)
  • K834461 — INFUSION PUMP PRIMER (January 30, 1984)
  • K831402 — PRESSURE MONITOR & CONTROL UNIT APC-02A (August 8, 1983)
  • K830818 — ASAHI BLOOD/PLASMA PUMP #ABP-01A & (April 12, 1983)

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