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510(k) K110723

M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS by Masimo Corporation — Product Code NLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2011
Date Received
March 16, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Masimo Corporation

  • K243324 — Masimo O3 Regional Oximeter (July 17, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K240229 — Masimo W1 (August 8, 2024)
  • K234021 — Masimo Stork (May 3, 2024)
  • K214115 — MightySat -OTC (January 31, 2024)
  • K223721 — Masimo Stork (December 15, 2023)
  • K232512 — Masimo W1 (November 17, 2023)
  • DEN200076 — ORi (October 12, 2023)
  • K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (September 7, 2023)

Other clearances for product code NLF

  • K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pul (October 22, 2024)
  • K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Puls (December 4, 2022)
  • K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-2 (March 8, 2022)
  • K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (July 22, 2020)
  • K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive (July 3, 2019)
  • K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (November 16, 2011)
  • K102560 — REPROCESSED PULSE OXIMETER SENSORS (February 18, 2011)
  • K101280 — MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (October 7, 2010)
  • K092368 — REPROCESSED PULSE OXIMETER SENSORS (November 3, 2009)
  • K083719 — LNCS OXIMETRY SENSORS (July 30, 2009)