FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
K Number: K051940
·
Decision Sep 28, 2005
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
3
Review Days
72
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Basic Information
- Device Name
- CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
- K Number
- K051940
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sis Ltd., Surgical Instrument Systems
- Date Received
- July 18, 2005
- Decision Date
- September 28, 2005
- Product Code
- MXK
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| MXK | Device, Analysis, Anterior Segment | FDA class 2 | Ophthalmic |
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