FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)
K Number: K093445
·
Decision Jan 19, 2010
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)
- K Number
- K093445
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Keeler, Ltd.
- Date Received
- October 21, 2009
- Decision Date
- January 19, 2010
- Product Code
- HKY
- 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 |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
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