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510(k) K854807

LIFE PAC by Lifemed Technologies, Inc. — Product Code KZD

K854807 is an FDA 510(k) premarket notification submitted by Lifemed Technologies, Inc. for the device "LIFE PAC". The FDA issued a decision of Substantially Equivalent on April 15, 1986. The device falls under product code KZD (Infusor, Pressure, For I.V. Bags), a Class I device regulated under 21 CFR 880.5420.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1986
Date Received
December 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infusor, Pressure, For I.V. Bags
Device Class
Class I
Regulation Number
880.5420
Review Panel
HO
Submission Type

Other clearances for product code KZD

  • K974074 — INFUSION DYNAMICS POWER INFUSER (February 17, 1998)
  • K973843 — MSI PRESSURE INFUSOR (October 29, 1997)
  • K953290 — OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP (October 7, 1995)
  • K951988 — PRESSURIZER (June 14, 1995)
  • K942933 — PRESSURE INFUSION CUFF (August 25, 1994)
  • K930012 — KAWASUMI LABORATORIES K-CUFF (December 14, 1993)
  • K921168 — ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (April 21, 1993)
  • K913751 — PRESSURE INFUSER (January 9, 1992)
  • K910926 — TECNADYNE SURGI-SQUEEZE INFUSION PUMP (August 2, 1991)
  • K911216 — INFUSABLE (July 22, 1991)

FDA data resources