Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- NUWStimulator, Muscle, Powered, Dental2Product Code
- K243290BTL-785MJ2Cleared 510(K)
- K203525D function2Cleared 510(K)
- K040400MYO-TRODE SG DISPOSABLE ELECTRODE2Cleared 510(K)
- K031998MODEL J-5 MVO-MONITOR2Cleared 510(K)
- K901902ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE2Cleared 510(K)
- K890143ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON2Cleared 510(K)
- K842223J4 MYO-MONITOR2Cleared 510(K)
- K842224BNS 402Cleared 510(K)
- K770252MONITOR, MYO, MODEL J32Cleared 510(K)
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
D function
- Page Type
- Cleared 510(K)
- 510(k) Number
- K203525
- 510(k) Type
- Traditional
- Applicant
- Ito Co., Ltd.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/5/2021
- Days to Decision
- 155 days
- Submission Type
- Summary