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510(k) K153046

HAMILTON-MR1 by Hamilton Medical AG — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2016
Date Received
October 19, 2015
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)
  • K201658 — Hamilton-C6 (December 11, 2020)
  • 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)
  • 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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