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510(k) K911216

INFUSABLE by Biomedical Dynamics, Inc. — Product Code KZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1991
Date Received
March 19, 1991
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 by Biomedical Dynamics, Inc.

  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K913751 — PRESSURE INFUSER (January 9, 1992)
  • K911213 — CUFFABLE (August 7, 1991)
  • K911324 — IRRIGATION/ASPIRATION TUBING SET (June 24, 1991)
  • K904376 — ANEROID BLOOD PRESSURE GAUGE (December 20, 1990)
  • K890268 — PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION (May 5, 1989)
  • K881799 — BLOOD PRESSURE CUFF (October 14, 1988)
  • K861977 — BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR (July 15, 1986)
  • K850506 — CORRECT FLO INTRAVASCULAR ADMINISTRATION SET (April 1, 1985)

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)
  • K904484 — BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (October 26, 1990)