Anesthesiology
Review Panel
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- Biological StainsCFR Sub-Part
- Clinical Chemistry Test SystemsCFR Sub-Part
- Clinical Laboratory InstrumentsCFR Sub-Part
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- Diagnostic DevicesCFR Sub-Part
- NDCCalculator, Drug Dose2Product Code
- K211160EndoTool SubQ 2.12Cleared 510(K)
- K203434BlueStar Rx2Cleared 510(K)
- K202596Insulia Diabetes Management Companion2Cleared 510(K)
- K201619EndoTool IV System2Cleared 510(K)
- K201337InPen System2Cleared 510(K)
- K200443EndoTool IV 1.102Cleared 510(K)
- K190487InPen Dose Calculator2Cleared 510(K)
- K192841InPen System2Cleared 510(K)
- K181916d-Nav System2Cleared 510(K)
- K180366EndoTool SubQ2Cleared 510(K)
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- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Immunological Test SystemsCFR Sub-Part
- Microbiology DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Pathology Instrumentation and AccessoriesCFR Sub-Part
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- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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EndoTool IV 1.10
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K200443
- 510(k) Type
- Traditional
- Applicant
- Monarch Medical Technologies, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/17/2020
- Days to Decision
- 22 days
- Submission Type
- Summary