Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—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)
Show All 27 Submissions
- 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
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- 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
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Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201699
- 510(k) Type
- Special
- Applicant
- Surgical Instrument and Savings Inc (dba Medline ReNewal)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/22/2020
- Days to Decision
- 30 days
- Submission Type
- Summary