FDA 510(k) Applications for Medical Device Product Code "NLF"
(Oximeter, Reprocessed)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K081238 | ASCENT HEALTHCARE SOLUTIONS | REPROCESSED MASIMO PULSE OXIMETER SENSORS | 07/29/2008 |
| K012600 | CLEAR MEDICAL, INC. | CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L | 07/03/2002 |
| K012609 | CLEAR MEDICAL, INC. | CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 | 07/03/2002 |
| K012622 | CLEAR MEDICAL, INC. | CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 | 07/03/2002 |
| K042891 | DATEX-OHMEDA | DATEX-OHMEDA OXY-AFR SENSOR | 06/29/2005 |
| K080424 | HYGIA HEALTH SERVICES, INC. | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 | 05/28/2008 |
| K012715 | HYGIA HEALTH SERVICES, INC. | HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II | 08/01/2003 |
| K041867 | HYGIA HEALTH SERVICES, INC. | HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N | 09/10/2004 |
| K083719 | MASIMO CORPORATION | LNCS OXIMETRY SENSORS | 07/30/2009 |
| K110723 | MASIMO CORPORATION | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS | 07/28/2011 |
| K101280 | MIDWEST REPROCESSING CENTER LLC | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE | 10/07/2010 |
| K033973 | NELLCOR PURITAN BENNETT, INC. | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | 12/13/2004 |
| K081927 | RENU MEDICAL, INC. | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | 02/06/2009 |
| K111773 | RENU MEDICAL, INC. | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | 11/16/2011 |
| K072194 | RENU MEDICAL, INC. | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | 11/29/2007 |
| K063661 | RENU MEDICAL, INC. | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | 05/25/2007 |
| K041127 | STERILMED, INC. | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | 09/23/2004 |
| K102560 | STERILMED, INC. | REPROCESSED PULSE OXIMETER SENSORS | 02/18/2011 |
| K012677 | STERILMED, INC. | REPROCESSED PULSE OXIMETER SENSORS | 03/28/2003 |
| K092368 | STERILMED, INC. | REPROCESSED PULSE OXIMETER SENSORS | 11/03/2009 |
| K211138 | Stryker Sustainability Solutions | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), R | 03/08/2022 |
| K222019 | Stryker Sustainability Solutions | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | 12/04/2022 |
| K201699 | Surgical Instrument and Savings Inc (dba Medline ReNewal) | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | 07/22/2020 |
| K191018 | Surgical Instrument Service and Savings Inc | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | 07/03/2019 |
| K012344 | VANGUARD MEDICAL CONCEPTS, INC. | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | 10/04/2002 |
| K042316 | VANGUARD MEDICAL CONCEPTS, INC. | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | 01/06/2005 |
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