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
- K042675FLEXI-STAT SP02 EAR SENSOR2Cleared 510(K)
- K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 35002Cleared 510(K)
- K012333FLEXI-SITE SP02 EAR SENSOR2Cleared 510(K)
- K010718FLEXI-SITE SP02 EAR SENSOR2Cleared 510(K)
- K944760DURA-Y OXYGEN TRANSDUCER, EAR CLIP2Cleared 510(K)
- K942752MARQUETTE EAR PROBE SENSOR2Cleared 510(K)
- K914595PULSE RATE MONITOR2Cleared 510(K)
- K862426PULSE OXIMETER2Cleared 510(K)
- K845051VITALOG PMS-82Cleared 510(K)
- K850494OHMEDA BIOX 3700 PULSE OXIMETER2Cleared 510(K)
Show All 11 Submissions
- DQAOximeter2Product Code
- NLFOximeter, Reprocessed2Product Code
- 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
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- General HospitalReview Panel
- HematologyReview Panel
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- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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FLEXI-STAT SP02 EAR SENSOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K042675
- 510(k) Type
- Traditional
- Applicant
- ELEKON INDUSTRIES U.S.A., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/6/2004
- Days to Decision
- 68 days
- Submission Type
- Summary