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510(k) K060790

BREAS, MODEL HA01 by Breas Medical AB — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2006
Date Received
March 23, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

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  • K160481 — Vivo 60 (November 9, 2016)
  • K090113 — BREAS VIVO 40 SYSTEM (May 14, 2009)
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  • K063476 — BREAS ISLEEP 20I (January 22, 2007)

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  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)