Anesthesiology
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- Diagnostic DevicesCFR Sub-Part
- ETKTube, Toynbee Diagnostic1Product Code
- ETMGustometer, Sterile1Product Code
- ETNStimulator, Nerve2Product Code
- K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long2Cleared 510(K)
- K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large2Cleared 510(K)
- K200886StimSite2Cleared 510(K)
- K152769FREMAP ELECTRODE2Cleared 510(K)
- K152505C2 NerveMonitor System2Cleared 510(K)
- K150005Checkpoint, Checkpoint Head & Neck2Cleared 510(K)
- K133348STIM PROBE2Cleared 510(K)
- K140400ES2 NEUROMONITORING ACCESSORY INSTRUMENTS2Cleared 510(K)
- K122040INVOTEC LARYNGEAL ELECTRODE2Cleared 510(K)
- K121931NONDISPOSABLE STIMULATING INSTRUMENTS2Cleared 510(K)
- Show All 86 Submissions
- ETPStimulator, Caloric-Water1Product Code
- ETRAdaptor, Short Increment Sensitivity Index (Sisi)1Product Code
- ETSGenerator, Electronic Noise (For Audiometric Testing)2Product Code
- ETTCushion, Earphone (For Audiometric Testing)1Product Code
- ETYTester, Auditory Impedance2Product Code
- EWASet, Audiometer Calibration1Product Code
- EWCChamber, Acoustic (For Audiometric Testing)1Product Code
- EWOAudiometer2Product Code
- KHHStimulator, Caloric-Air1Product Code
- KLXElectroglottograph2Product Code
- LYNApparatus, Visual Reinforcement Audiometric2Product Code
- NASTympanometer2Product Code
- NNJGustometer, Non-Sterile1Product Code
- NRKKit, Test, Olfactory2Product Code
- PTOTester, Auditory Impedance, Exempt2Product Code
- PTPTympanometer, Exempt2Product Code
- LWIUltrasound, Sinus2Product Code
- PSVUltrasound Bronchoscope2Product Code
- QJGDevice System, Imaging, Tympanic Membrane And Middle Ear2Product Code
- QQEImage Management Software For Planning Of Otologic And Neurotologic Procedures2Product Code
- General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Miscellaneous DevicesCFR Sub-Part
- Neurological Surgical DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
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C2 NerveMonitor System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K152505
- 510(k) Type
- Traditional
- Applicant
- INOMED MEDIZINTECHNIK GMBH
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/1/2016
- Days to Decision
- 152 days
- Submission Type
- Summary