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
- K230172Pulse Oximeter2Cleared 510(K)
- K211143Pulse Oximeter2Cleared 510(K)
- K222597BabySat 32Cleared 510(K)
- K221798Finger Pulse Oximeter, Model: X1906P2Cleared 510(K)
- K213676Masimo Rad-G with Temperature2Cleared 510(K)
- K220101Pulse Oximeter2Cleared 510(K)
- K213431Handheld Pulse Oximeter2Cleared 510(K)
- K222010Biobeat Platform-2 and BB-613WP Patch2Cleared 510(K)
- K213430Fingertip Pulse Oximeter2Cleared 510(K)
- K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)2Cleared 510(K)
- Show All 684 Submissions
- NLFOximeter, Reprocessed2Product 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
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Fingertip Pulse Oximeter
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213430
- 510(k) Type
- Traditional
- Applicant
- Shenzhen Witleaf Medical Electronics Co.,Ltd
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/30/2022
- Days to Decision
- 435 days
- Submission Type
- Summary