510(k) K033973

OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR by Nellcor Puritan Bennett, Inc. — Product Code NLF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 13, 2004
Date Received: December 22, 2003
Clearance Type: Traditional
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 Nellcor Puritan Bennett, Inc.

K070899 — PURITAN BENNETT LEGENDAIR XL2 (December 13, 2007)
K070408 — DURAMAX REUSABLE OXIMETRY SENSOR (May 25, 2007)
K060576 — NELLCOR OXIMAX N-600X PULSE OXIMETER (August 14, 2006)
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)
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 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)
K110723 — M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS (July 28, 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)