Home / 510(k) Clearances / K060576

510(k) K060576

NELLCOR OXIMAX N-600X PULSE OXIMETER by Nellcor Puritan Bennett, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2006
Date Received
March 6, 2006
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 Nellcor Puritan Bennett, Inc.

  • K070899 — PURITAN BENNETT LEGENDAIR XL2 (December 13, 2007)
  • K070408 — DURAMAX REUSABLE OXIMETRY SENSOR (May 25, 2007)
  • K051271 — OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR (January 10, 2006)
  • K052186 — NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (November 10, 2005)
  • K051352 — OXIMAX NPB-40 HANDHELD PULSE OXIMETER (August 11, 2005)
  • K050072 — GOODKNIGHT 425ST (June 13, 2005)
  • K033973 — OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR (December 13, 2004)
  • K030787 — SHILEY FLEXTRA TRACHEOSTOMY TUBE (November 14, 2003)
  • K030930 — OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N (May 23, 2003)
  • K023494 — NELLCOR INDGO MANUAL RESUSCITATOR (February 7, 2003)

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)