Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- QLSPulse Oximeter For Low-Acuity Settings2Product Code
- PGJOximeter, Wellness2Product Code
- DPZOximeter, Ear2Product Code
- DQAOximeter2Product Code
- NLFOximeter, Reprocessed2Product Code
- K241758Reprocessed 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)2Cleared 510(K)
- K222019Reprocessed 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)2Cleared 510(K)
- 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), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)2Cleared 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)
- OLKPulse Oximeter For Over-The-Counter Use2Product Code
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
DATEX-OHMEDA OXY-AFR SENSOR
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K042891
- 510(k) Type
- Traditional
- Applicant
- Datex-Ohmeda
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/29/2005
- Days to Decision
- 253 days
- Submission Type
- Summary