FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
E-Cath STIM acc. Tsui
K Number: K202699
·
Decision Dec 29, 2020
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
44
Review Days
104
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Basic Information
- Device Name
- E-Cath STIM acc. Tsui
- K Number
- K202699
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PAJUNK GmbH Medizintechnologie
- Date Received
- September 16, 2020
- Decision Date
- December 29, 2020
- 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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