FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM 10
K Number: K820678
·
Decision Mar 23, 1982
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
5
Review Days
12
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Basic Information
- Device Name
- SYSTEM 10
- K Number
- K820678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Biostim, Inc.
- Date Received
- March 11, 1982
- Decision Date
- March 23, 1982
- Product Code
- GZJ
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Biostim, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844023 | AQUAFORM ELECTRODES WITH AQUAPORE | Feb 1, 1985 | Substantially Equivalent |
| K840725 | CLINICAL CARE STIMULATOR | Apr 18, 1984 | Substantially Equivalent |
| K840724 | MUSCLE STIMULATOR X-10 | Mar 5, 1984 | Substantially Equivalent |
| K802227 | ANASTIM II TRANSCUTANEOUS ELECTRICAL | Sep 26, 1980 | Substantially Equivalent |