FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ALGO 7i
K Number: K211147
·
Decision Oct 14, 2021
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
6
Review Days
178
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Basic Information
- Device Name
- ALGO 7i
- K Number
- K211147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Path Medical GmbH
- Date Received
- April 19, 2021
- Decision Date
- October 14, 2021
- Product Code
- GWJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Path Medical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K220139 | QScreen | Aug 3, 2022 | Substantially Equivalent |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Jun 22, 2022 | Substantially Equivalent |
| K133012 | SENTIERO | Jun 9, 2014 | Substantially Equivalent |
| K131141 | EARPROBE | Jun 27, 2013 | Substantially Equivalent |
| K100661 | EARPROBE | Jul 1, 2010 | Substantially Equivalent |