FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K Number: K113188
·
Decision Mar 1, 2012
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
154
Applicant Total
25
Review Days
122
Basic Information
- Device Name
- SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
- K Number
- K113188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Date Received
- October 31, 2011
- Decision Date
- March 1, 2012
- Product Code
- CAZ
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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