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510(k) K801890

IC-2 VENTILATOR by Bio-Med Devices, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1980
Date Received
August 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Bio-Med Devices, Inc.

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  • K896381 — MVP-10 MRI INFANT VENTILATOR (February 12, 1990)
  • K896380 — IC-2A MRI ADULT/PEDIATRIC VENTILATOR (February 12, 1990)
  • K873614 — CBG CUFF MANOMETER (January 22, 1988)
  • K871336 — M-1 PRESSURE MONITOR (June 5, 1987)
  • K871337 — M-2 OXYGEN/TEMPERATURE MONITOR (June 5, 1987)
  • K871139 — M-10 VENTILATION MONITOR (April 21, 1987)
  • K830230 — PROGRAMMABLE VENTILATOR (February 9, 1983)

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