FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
NEUROTECH MEDISTIM PLUS, TYPE 291
K Number: K014019
·
Decision Jul 11, 2002
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
543
Applicant Total
27
Review Days
217
Basic Information
- Device Name
- NEUROTECH MEDISTIM PLUS, TYPE 291
- K Number
- K014019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIO-MEDICAL RESEARCH, LTD.
- Date Received
- December 6, 2001
- Decision Date
- July 11, 2002
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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