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510(k) K201658

Hamilton-C6 by Hamilton Medical AG — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2020
Date Received
June 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Hamilton Medical AG

  • K201306 — HAMILTON-C3 (February 5, 2021)
  • K193228 — Hamilton-G5 (May 4, 2020)
  • K181216 — HAMILTON-T1, HAMILTON-C1 (August 2, 2019)
  • K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 (September 20, 2017)
  • 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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