FDA 510(k)
FDA unclassified
Substantially Equivalent
🇦🇹 Austria
Stivax
K Number: K152571
·
Decision May 26, 2016
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
22
Applicant Total
3
Review Days
260
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Basic Information
- Device Name
- Stivax
- K Number
- K152571
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biegler GmbH
- Date Received
- September 9, 2015
- Decision Date
- May 26, 2016
- Product Code
- BWK
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| BWK | Stimulator, Electro-Acupuncture | FDA unclassified | Unknown |
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