FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
P-STIM
K Number: K140788
·
Decision Jun 27, 2014
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
22
Applicant Total
3
Review Days
88
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Basic Information
- Device Name
- P-STIM
- K Number
- K140788
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biegler GmbH
- Date Received
- March 31, 2014
- Decision Date
- June 27, 2014
- 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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