FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
K Number: K981665
·
Decision Dec 7, 1998
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
4
Applicant Total
3
Review Days
210
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Basic Information
- Device Name
- SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
- K Number
- K981665
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Medical Sciences, Inc.
- Date Received
- May 11, 1998
- Decision Date
- December 7, 1998
- Product Code
- MMQ
- 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 |
|---|---|---|---|
| MMQ | Topographer, Corneal, Ac-Powered | FDA class 1 | Ophthalmic |
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