NLF — Oximeter, Reprocessed Class II
Classification Details
- Product Code
- NLF
- Device Class
- Class II
- Regulation Number
- 870.2700
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241758 | stryker sustainability solutions | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pul | October 22, 2024 |
| K222019 | stryker sustainability solutions | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Puls | December 4, 2022 |
| K211138 | stryker sustainability solutions | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-2 | March 8, 2022 |
| K201699 | surgical instrument and savings inc (dba medline renewal) | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | July 22, 2020 |
| K191018 | surgical instrument service and savings | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive | July 3, 2019 |
| K111773 | renu medical | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | November 16, 2011 |
| K110723 | masimo corporation | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS | July 28, 2011 |
| K102560 | sterilmed | REPROCESSED PULSE OXIMETER SENSORS | February 18, 2011 |
| K101280 | midwest reprocessing center | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE | October 7, 2010 |
| K092368 | sterilmed | REPROCESSED PULSE OXIMETER SENSORS | November 3, 2009 |
| K083719 | masimo corporation | LNCS OXIMETRY SENSORS | July 30, 2009 |
| K081927 | renu medical | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | February 6, 2009 |
| K081238 | ascent healthcare solutions | REPROCESSED MASIMO PULSE OXIMETER SENSORS | July 29, 2008 |
| K080424 | hygia health services | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1 | May 28, 2008 |
| K072194 | renu medical | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | November 29, 2007 |
| K063661 | renu medical | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | May 25, 2007 |
| K042891 | datex-ohmeda | DATEX-OHMEDA OXY-AFR SENSOR | June 29, 2005 |
| K042316 | vanguard medical concepts | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | January 6, 2005 |
| K033973 | nellcor puritan bennett | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | December 13, 2004 |
| K041127 | sterilmed | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | September 23, 2004 |