FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
Myo Plus
K Number: K191179
·
Decision Sep 4, 2019
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
3
Review Days
125
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Basic Information
- Device Name
- Myo Plus
- K Number
- K191179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Otto Bock Healthcare Products GmbH
- Date Received
- May 2, 2019
- Decision Date
- September 4, 2019
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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