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510(k) K221798

Finger Pulse Oximeter, Model: X1906P by Shenzhen Changkun Technology Co., Ltd. — Product Code DQA

K221798 is an FDA 510(k) premarket notification submitted by Shenzhen Changkun Technology Co., Ltd. for the device "Finger Pulse Oximeter, Model: X1906P". The FDA issued a decision of Substantially Equivalent on May 4, 2023. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Changkun Technology Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2023
Date Received
June 21, 2022
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 Shenzhen Changkun Technology Co., Ltd.

  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (May 6, 2026)
  • K231595 — Electric Breast Pump (October 26, 2023)
  • K193387 — Arm Electronic Sphygmomanometer (January 27, 2021)
  • K193386 — Wrist Electronic Sphygmomanometer (January 27, 2021)
  • K193253 — Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (June 17, 2020)

Other clearances for product code DQA

  • K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor ( (May 29, 2026)
  • K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, P (May 11, 2026)
  • K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Na (May 1, 2026)
  • K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (April 14, 2026)
  • 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)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)

FDA data resources