FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000
K Number: K971437
·
Decision Jul 22, 1997
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
7
Applicant Total
3
Review Days
95
Basic Information
- Device Name
- BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000
- K Number
- K971437
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MURRAY ELECTRONICS
- Date Received
- April 18, 1997
- Decision Date
- July 22, 1997
- Product Code
- NYN
- 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 |
|---|---|---|---|
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | FDA class 2 | Neurology |
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