FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BLUE 400; BLUE 400 S
K Number: K240215
·
Decision Jun 28, 2024
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
4
Applicant Total
45
Review Days
154
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Basic Information
- Device Name
- BLUE 400; BLUE 400 S
- K Number
- K240215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, AG
- Date Received
- January 26, 2024
- Decision Date
- June 28, 2024
- Product Code
- QFX
- 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 |
|---|---|---|---|
| QFX | Diagnostic Neurosurgical Microscope Filter | FDA class 2 | Neurology |
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Other Clearances by Carl Zeiss Meditec, AG
| K Number | Device Name | ||
|---|---|---|---|
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| K233911 | VISULAS combi | Sep 6, 2024 | Substantially Equivalent |
| K233421 | RESCAN 700 | Mar 8, 2024 | Substantially Equivalent |
| K232944 | CALLISTO eye | Dec 21, 2023 | Substantially Equivalent |
| K232159 | QEVO System | Sep 21, 2023 | Substantially Equivalent |
| K231676 | CALLISTO eye | Aug 28, 2023 | Substantially Equivalent |
| K230858 | QUATERA 700 | Jul 31, 2023 | Substantially Equivalent |
| K213527 | FORUM | Aug 15, 2022 | Substantially Equivalent |
| K211346 | BLUE 400 | Jul 22, 2022 | Substantially Equivalent |
| K212241 | QUATERA 700 | Apr 19, 2022 | Substantially Equivalent |