FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
GALVA 5-T
K Number: K960969
·
Decision May 15, 1996
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
12
Review Days
65
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Basic Information
- Device Name
- GALVA 5-T
- K Number
- K960969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zimmer Elektromedizin GmbH
- Date Received
- March 11, 1996
- Decision Date
- May 15, 1996
- 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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| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | May 7, 1985 | Substantially Equivalent |