FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BACPAC (TM), MODEL 6500
K Number: K864968
·
Decision Mar 13, 1987
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
49
Review Days
81
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Basic Information
- Device Name
- BACPAC (TM), MODEL 6500
- K Number
- K864968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Medical Devices, Inc.
- Date Received
- December 22, 1986
- Decision Date
- March 13, 1987
- 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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