FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
Maestro System (REF100)
K Number: K240598
·
Decision Jun 3, 2024
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
34
Applicant Total
4
Review Days
91
Basic Information
- Device Name
- Maestro System (REF100)
- K Number
- K240598
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Moon Surgical
- Date Received
- March 4, 2024
- Decision Date
- June 3, 2024
- Product Code
- FQO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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