Home / 510(k) Clearances / K142959

510(k) K142959

Vyntus Walk by Carefusion Germany 234 GmbH — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
October 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Carefusion Germany 234 GmbH

  • K153654 — Sentry WEB SmartInterp (September 16, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K141936 — MICROBLAB, MICROLOOP (December 29, 2014)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K122699 — SENTRYSUITE PRODUCT LINE (November 19, 2012)
  • K113813 — SENTRYSUITE PRODUCT LINE (May 10, 2012)
  • K113096 — MICRO I (April 13, 2012)
  • K111408 — MICROGARD II (October 17, 2011)
  • K111053 — SENTRYSUITE PRODUCT LINE (August 12, 2011)
  • K101873 — MASTERSCREEN IOS (February 10, 2011)

Other clearances for product code DQA

  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (February 17, 2026)
  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)