FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
STIMUPLEX PEN
K Number: K061983
·
Decision Nov 21, 2006
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
62
Applicant Total
5
Review Days
131
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Basic Information
- Device Name
- STIMUPLEX PEN
- K Number
- K061983
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stockert GmbH
- Date Received
- July 13, 2006
- Decision Date
- November 21, 2006
- Product Code
- BXN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | FDA class 2 | Anesthesiology |
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Other Clearances by Stockert GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K070336 | STOCKERT NEURO N50, MODEL12267 | Jun 14, 2007 | Substantially Equivalent |
| K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | Mar 22, 2007 | Substantially Equivalent |
| K052313 | STIMUPLEX HNS-12, MODEL 4892098 | Nov 17, 2005 | Substantially Equivalent |
| K003983 | STIMUPLEX HNS-11 | Jun 6, 2001 | Substantially Equivalent |