FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SINUS AC-POWERED MUSCLE STIMULATOR
K Number: K850453
·
Decision May 7, 1985
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
543
Applicant Total
12
Review Days
90
Basic Information
- Device Name
- SINUS AC-POWERED MUSCLE STIMULATOR
- K Number
- K850453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- ZIMMER ELEKTROMEDIZIN GMBH
- Date Received
- February 6, 1985
- Decision Date
- May 7, 1985
- 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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