FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SELECTRODE SYSTEM
K Number: K832634
·
Decision Jan 25, 1984
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
22
Applicant Total
4
Review Days
174
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Basic Information
- Device Name
- SELECTRODE SYSTEM
- K Number
- K832634
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Bio-Stimu Trend Corp.
- Date Received
- August 4, 1983
- Decision Date
- January 25, 1984
- 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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