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510(k) K240163

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula by Medline Industries, LP — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2024
Date Received
January 22, 2024
Clearance Type
Traditional
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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Other clearances for product code BTT

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  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)
  • K233821 — F&P Optiflow Oxygen Kit (AA451J) (June 13, 2024)