510(k) K904376

ANEROID BLOOD PRESSURE GAUGE by Biomedical Dynamics, Inc. — Product Code FCY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 20, 1990
Date Received: September 25, 1990
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bulb, Inflation, For Endoscope
Device Class: Class I
Regulation Number: 876.1500
Review Panel: GU
Submission Type

An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.

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)
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)

510(k) K904376

Clearance Details

Device Classification

Other clearances by Biomedical Dynamics, Inc.

Other clearances for product code FCY