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510(k) K913751

PRESSURE INFUSER by Biomedical Dynamics, Inc. — Product Code KZD

K913751 is an FDA 510(k) premarket notification submitted by Biomedical Dynamics, Inc. for the device "PRESSURE INFUSER". The FDA issued a decision of Substantially Equivalent on January 9, 1992. The device falls under product code KZD (Infusor, Pressure, For I.V. Bags), a Class I device regulated under 21 CFR 880.5420. Biomedical Dynamics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1992
Date Received
August 21, 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)
  • K911213 — CUFFABLE (August 7, 1991)
  • K911216 — INFUSABLE (July 22, 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)
  • K910926 — TECNADYNE SURGI-SQUEEZE INFUSION PUMP (August 2, 1991)
  • K911216 — INFUSABLE (July 22, 1991)
  • K904484 — BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (October 26, 1990)

FDA data resources