FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
K Number: K121743
·
Decision Mar 28, 2013
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
1
Review Days
288
Basic Information
- Device Name
- EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
- K Number
- K121743
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SUNMED LLC
- Date Received
- June 13, 2012
- Decision Date
- March 28, 2013
- 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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