Home / 510(k) Clearances / K831402

510(k) K831402

PRESSURE MONITOR & CONTROL UNIT APC-02A by Parker Hannifin Corp. — Product Code KXM

K831402 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corp. for the device "PRESSURE MONITOR & CONTROL UNIT APC-02A". The FDA issued a decision of Substantially Equivalent on August 8, 1983. The device falls under product code KXM (System Accessories, Extracorporeal), a Class II device regulated under 21 CFR 876.5820. Parker Hannifin Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1983
Date Received
May 2, 1983
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 Parker Hannifin Corp.

  • K202480 — Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (April 22, 2021)
  • K161731 — Cleveland Multiport Ventricular Catheter Set (March 27, 2017)
  • 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)
  • K831747 — PLASMA THERAPY TUBESET-E100 SERIES (June 30, 1983)
  • K830818 — ASAHI BLOOD/PLASMA PUMP #ABP-01A & (April 12, 1983)

Other clearances for product code KXM

  • K925581 — BAXTER BIOSTAT 1000 UREA MONITOR (May 3, 1995)
  • K863471 — COLORADO MEDICAL MODEL PTC 1000 (October 2, 1986)
  • K853536 — VELCRO FISTULA PRESSURE CLAMPS (October 17, 1985)

FDA data resources