Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- IKNElectromyograph, Diagnostic2Product Code
- K172743Natus VikingQuest2Cleared 510(K)
- K163150ViMove22Cleared 510(K)
- K162383Cadwell Sierra Summit, Cadwell Sierra Ascent2Cleared 510(K)
- K142494ViMove2Cleared 510(K)
- K131094VIMOVE2Cleared 510(K)
- K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)2Cleared 510(K)
- K123399MYOVISION 3.0 WIREFREE SYSTEM2Cleared 510(K)
- K113074CMAP PRO2Cleared 510(K)
- K102610FOCUS EMG DEVICE2Cleared 510(K)
- K110048CERSR ELECTROMYOGRAPHY SYSTEM2Cleared 510(K)
- Show All 73 Submissions
- IKTElectrode, Needle, Diagnostic Electromyograph2Product Code
- LYHArthrometer1Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical 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
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
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Cadwell Sierra Summit, Cadwell Sierra Ascent
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K162383
- 510(k) Type
- Traditional
- Applicant
- CADWELL INDUSTRIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/1/2017
- Days to Decision
- 188 days
- Submission Type
- Summary