FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MEA110
K Number: K843822
·
Decision Oct 22, 1984
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
2
Review Days
24
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Basic Information
- Device Name
- MEA110
- K Number
- K843822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Canadian Medical Products
- Date Received
- September 28, 1984
- Decision Date
- October 22, 1984
- 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 Canadian Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K820326 | BIGSTON TRANSCUTANEOUS NERVE STIMULAT | Apr 29, 1982 | Substantially Equivalent |