FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
K Number: K093213
·
Decision Mar 12, 2010
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
40
Applicant Total
29
Review Days
150
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Basic Information
- Device Name
- GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
- K Number
- K093213
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1605
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, Inc.
- Date Received
- October 13, 2009
- Decision Date
- March 12, 2010
- Product Code
- HPT
- 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 |
|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | FDA class 1 | Ophthalmic |
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