Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GZCStimulator, Neuromuscular, Implanted3Product Code
- QPLElectromagnetic Stimulator, Pain Relief2Product Code
- K250309BTL-1992Cleared 510(K)
- K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)2Cleared 510(K)
- K241785StarFormer (M008-3T)2Cleared 510(K)
- K233364Axon Therapy2Cleared 510(K)
- K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption2Cleared 510(K)
- K210021Axon Therapy2Cleared 510(K)
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K230014
- 510(k) Type
- Traditional
- Applicant
- Tonica Elektronik A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/25/2023
- Days to Decision
- 234 days
- Submission Type
- Summary