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510(k) K163283

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 by Hamilton Medical AG — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2017
Date Received
November 21, 2016
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

Other clearances by Hamilton Medical AG

  • K201306 — HAMILTON-C3 (February 5, 2021)
  • K201658 — Hamilton-C6 (December 11, 2020)
  • K193228 — Hamilton-G5 (May 4, 2020)
  • K181216 — HAMILTON-T1, HAMILTON-C1 (August 2, 2019)
  • K161450 — HAMILTON-C3 (April 27, 2017)
  • K153046 — HAMILTON-MR1 (September 6, 2016)
  • K152029 — HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC401 (May 3, 2016)
  • K150893 — IntelliCuff (January 29, 2016)
  • K140939 — HAMILTON-T1,HAMILTON-C1 (September 2, 2015)
  • K122438 — HAMILTON-MR1 (November 20, 2013)

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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)
  • 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)