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510(k) K800125

VENTILATOR TEST LUNG by Bio-Med Devices, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1980
Date Received
January 18, 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.

  • K213948 — OxyMinder (March 17, 2022)
  • K173973 — TV-100 (July 20, 2018)
  • K942938 — CROSSVENT-4 VENTILATOR (September 19, 1995)
  • K896380 — IC-2A MRI ADULT/PEDIATRIC VENTILATOR (February 12, 1990)
  • K896381 — MVP-10 MRI INFANT VENTILATOR (February 12, 1990)
  • K873614 — CBG CUFF MANOMETER (January 22, 1988)
  • K871337 — M-2 OXYGEN/TEMPERATURE MONITOR (June 5, 1987)
  • K871336 — M-1 PRESSURE MONITOR (June 5, 1987)
  • K871139 — M-10 VENTILATION MONITOR (April 21, 1987)
  • K830230 — PROGRAMMABLE VENTILATOR (February 9, 1983)

Other clearances for product code CBK

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  • K251888 — VPAP Pediatric Face Mask (March 12, 2026)
  • K232365 — Vivo 45 LS (December 19, 2025)
  • K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits (September 10, 2025)
  • K243767 — SV600, SV800 Ventilator (August 28, 2025)
  • K251133 — AVEA disposable expiratory filter/water trap (11790) (May 8, 2025)
  • K243394 — AF531 Oro-Nasal SE Face Mask (December 30, 2024)
  • K233486 — 731 Series Ventilator (December 13, 2024)
  • K223120 — Ventoux VC2; Ventoux VC3 (December 2, 2024)