FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORBSCAN
K Number: K984443
·
Decision Mar 5, 1999
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
10
Review Days
81
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Basic Information
- Device Name
- ORBSCAN
- K Number
- K984443
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Technolas Perfect Vision GmbH
- Date Received
- December 14, 1998
- Decision Date
- March 5, 1999
- 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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