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510(k) K890268

PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION by Biomedical Dynamics, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1989
Date Received
January 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
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)
  • K911216 — INFUSABLE (July 22, 1991)
  • K911324 — IRRIGATION/ASPIRATION TUBING SET (June 24, 1991)
  • K904376 — ANEROID BLOOD PRESSURE GAUGE (December 20, 1990)
  • 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)

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