FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MACH LED 2MC
K Number: K140461
·
Decision Apr 3, 2014
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
4
Review Days
38
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Basic Information
- Device Name
- MACH LED 2MC
- K Number
- K140461
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dr. Mach GmbH & Co. KG
- Date Received
- February 24, 2014
- Decision Date
- April 3, 2014
- Product Code
- FSY
- 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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | FDA class 2 | General, Plastic Surgery |
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