FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Brainlab Elements Guide XT, Guide 3.0
K Number: K213930
·
Decision Apr 19, 2022
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
47
Review Days
124
Basic Information
- Device Name
- Brainlab Elements Guide XT, Guide 3.0
- K Number
- K213930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5855
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brainlab AG
- Date Received
- December 16, 2021
- Decision Date
- April 19, 2022
- Product Code
- QQC
- 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 |
|---|---|---|---|
| QQC | Brain Stimulation Programming Planning Software. | FDA class 2 | Neurology |
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