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510(k) K873614

CBG CUFF MANOMETER by Bio-Med Devices, Inc. — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1988
Date Received
September 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

Other clearances by Bio-Med Devices, Inc.

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  • 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)
  • 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)
  • K823861 — ET-3 EMERGENCY TRANSPORT VENTILATOR (February 7, 1983)

Other clearances for product code BSK

  • K243562 — CuffGuard (August 12, 2025)
  • K242642 — CuffTrek (March 7, 2025)
  • K220854 — TrachCuff Cuff Controller (April 14, 2023)
  • K221477 — AG100s (December 29, 2022)
  • K202874 — Puritan Bennett Cuff Pressure Manager (January 9, 2021)
  • K192611 — Cuffix (August 13, 2020)
  • K191858 — Pylant Monitor (February 24, 2020)
  • K182548 — Accucuff Cuff Pressure Indicator (January 25, 2019)
  • K180991 — AG 100s (October 12, 2018)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)