Home / 510(k) Clearances / K140939

510(k) K140939

HAMILTON-T1,HAMILTON-C1 by Hamilton Medical AG — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2015
Date Received
April 11, 2014
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)
  • 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)
  • K122438 — HAMILTON-MR1 (November 20, 2013)

Other clearances for product code CBK

  • K251888 — VPAP Pediatric Face Mask (March 12, 2026)
  • K232365 — Vivo 45 LS (December 19, 2025)
  • K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits (September 10, 2025)
  • K243767 — SV600, SV800 Ventilator (August 28, 2025)
  • K251133 — AVEA disposable expiratory filter/water trap (11790) (May 8, 2025)
  • K243394 — AF531 Oro-Nasal SE Face Mask (December 30, 2024)
  • K233486 — 731 Series Ventilator (December 13, 2024)
  • K223120 — Ventoux VC2; Ventoux VC3 (December 2, 2024)
  • K241135 — RESPOND(R) Ventilator (November 13, 2024)
  • K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 (August 28, 2024)