FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PACHYCAM
K Number: K041841
·
Decision Jan 28, 2005
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
6
Review Days
204
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Basic Information
- Device Name
- PACHYCAM
- K Number
- K041841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oculus Optikgerate GmbH
- Date Received
- July 8, 2004
- Decision Date
- January 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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