Anesthesiology
Review Panel
- Cardiovascular Diagnostic DevicesCFR Sub-Part
- Cardiovascular Monitoring DevicesCFR Sub-Part
- QLSPulse Oximeter For Low-Acuity Settings2Product Code
- PGJOximeter, Wellness2Product Code
- DPZOximeter, Ear2Product Code
- DQAOximeter2Product Code
- NLFOximeter, Reprocessed2Product Code
- K211138Reprocessed 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), Reprocessed Pulse Oximeter Sensor (Max-AL), R2Cleared 510(K)
- K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor2Cleared 510(K)
- K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors2Cleared 510(K)
- K111773RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE2Cleared 510(K)
- K110723M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS2Cleared 510(K)
- K102560REPROCESSED PULSE OXIMETER SENSORS2Cleared 510(K)
- K101280MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE2Cleared 510(K)
- K092368REPROCESSED PULSE OXIMETER SENSORS2Cleared 510(K)
- K083719LNCS OXIMETRY SENSORS2Cleared 510(K)
- K081927RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO2Cleared 510(K)
- K081238REPROCESSED MASIMO PULSE OXIMETER SENSORS2Cleared 510(K)
- K080424HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-18612Cleared 510(K)
- K072194RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-252Cleared 510(K)
- K063661RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-202Cleared 510(K)
- K042891DATEX-OHMEDA OXY-AFR SENSOR2Cleared 510(K)
- K042316VANGUARD REPROCESSED PULSE OXIMETER SENSORS2Cleared 510(K)
- K033973OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR2Cleared 510(K)
- K041127MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS2Cleared 510(K)
- K041867HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N2Cleared 510(K)
- K012715HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II2Cleared 510(K)
- K012677REPROCESSED PULSE OXIMETER SENSORS2Cleared 510(K)
- K012344VANGUARD REPROCESSED PULSE OXIMETER SENSORS2Cleared 510(K)
- K012622CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-202Cleared 510(K)
- K012609CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-252Cleared 510(K)
- K012600CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L2Cleared 510(K)
- Cardiovascular Therapeutic DevicesCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousCFR Sub-Part
- Monitoring DevicesCFR Sub-Part
- Neurological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- CardiovascularReview Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
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- Obstetrical and GynecologicalReview Panel
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- PathologyReview Panel
- Physical MedicineReview Panel
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- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
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- UnknownReview Panel
OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K033973
- 510(k) Type
- Traditional
- Applicant
- NELLCOR PURITAN BENNETT, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/13/2004
- Days to Decision
- 357 days
- Submission Type
- Summary