Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- QDJDirect-To-Consumer Access Pharmacogenetic Assessment System2Product Code
- MXASystem, Test, Breath Nitric Oxide2Product Code
- K243926Vivatmo pro-S2Cleared 510(K)
- K233775Vivatmo pro2Cleared 510(K)
- K213611Fenom Pro2Cleared 510(K)
- K203695NObreath®2Cleared 510(K)
- K182874Fenom Pro Nitric Oxide Test2Cleared 510(K)
- K170983NIOX VERO2Cleared 510(K)
- K150233NIOX VERO Airway Inflammation Monitor2Cleared 510(K)
- K133898NIOX VERO AIRWAY INFLAMMATION MONITOR2Cleared 510(K)
- K123683NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR2Cleared 510(K)
- K101034NIOX MINO MODEL 09-10002Cleared 510(K)
Show All 14 Submissions
- OICBlood Alcohol Kit (Excludes Hiv Testing)2Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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Fenom Pro
- Page Type
- Cleared 510(K)
- 510(k) Number
- K213611
- 510(k) Type
- Traditional
- Applicant
- CAIRE Diagnostics Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/7/2023
- Days to Decision
- 569 days
- Submission Type
- Summary