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510(k) K120079

PRIMED TRACHEOSTOMY TUBES (MULTIPLE) by Primed Halberstadt Medizintechnik GmbH — Product Code BTO

K120079 is an FDA 510(k) premarket notification submitted by Primed Halberstadt Medizintechnik GmbH for the device "PRIMED TRACHEOSTOMY TUBES (MULTIPLE)". The FDA issued a decision of Substantially Equivalent on May 24, 2012. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2012
Date Received
January 10, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

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  • K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PRE (April 23, 2010)
  • K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (August 18, 2009)
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FDA data resources