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510(k) K160582

WiCap by Athena Gtx — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2016
Date Received
March 1, 2016
Clearance Type
Abbreviated
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 Athena Gtx

  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)
  • K191989 — WVSM (Wireless Vital Signs Monitor) RWC + miniCap (January 29, 2020)
  • K173203 — Athena GTX Device Management Suite (ADMS) Software (March 14, 2018)
  • K153459 — TACVAC (January 28, 2016)
  • K130957 — WVSM (WIRLESS VITAL SIGNS MONITOR) (April 30, 2013)
  • K113165 — MINI-MEDIC (February 2, 2012)
  • K101674 — WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 (July 21, 2010)

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)