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510(k) K041644

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) by Elekon Industries U.S.A., Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2004
Date Received
June 17, 2004
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 Elekon Industries U.S.A., Inc.

  • K042705 — DISPOSABLE NON-ADHESIVE SPO2 SENSORS (December 29, 2004)
  • K042675 — FLEXI-STAT SP02 EAR SENSOR (December 6, 2004)
  • K042704 — REUSABLE FINGER CLIP SPO2 SENSORS (November 26, 2004)
  • K041522 — FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS (September 14, 2004)
  • K041647 — FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBL (September 2, 2004)

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)