FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MyCRO Band
K Number: K201426
·
Decision Mar 26, 2021
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
42
Applicant Total
17
Review Days
301
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Basic Information
- Device Name
- MyCRO Band
- K Number
- K201426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5970
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Otto Bock Healthcare LP
- Date Received
- May 29, 2020
- Decision Date
- March 26, 2021
- Product Code
- MVA
- 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 |
|---|---|---|---|
| MVA | Orthosis, Cranial | FDA class 2 | Neurology |
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