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
- K212752Med-link Pulse Oximeter2Cleared 510(K)
- K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC2Cleared 510(K)
- K212153Biobeat Platform, BB-613WP Patch2Cleared 510(K)
- K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult2Cleared 510(K)
- K212300Pulse Oximeter2Cleared 510(K)
- K211400Pulse Oximeter2Cleared 510(K)
- K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)2Cleared 510(K)
- K210305Pulse Oximeter2Cleared 510(K)
- K211407Belun Ring BLR-100X2Cleared 510(K)
- K212876Carescape SpO2 - Masimo2Cleared 510(K)
- Show All 664 Submissions
- NLFOximeter, Reprocessed2Product Code
- 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
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Carescape SpO2 - Masimo
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K212876
- 510(k) Type
- Special
- Applicant
- Masimo Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/8/2021
- Days to Decision
- 29 days
- Submission Type
- Summary