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510(k) K152778

TRACOE Cuff Pressure Monitor by Tracoe Medical GmbH — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2016
Date Received
September 25, 2015
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 Tracoe Medical GmbH

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  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
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  • K051587 — TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, (October 25, 2005)
  • K043160 — TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO (February 18, 2005)
  • K961449 — TRACHEOSTOMY TUBES TRACOE-FLEX (September 13, 1996)
  • K781729 — TRACHEOTOMY TUBES (October 24, 1978)

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  • 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)