FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D-KAT Z-YPE
K Number: K142179
·
Decision Sep 17, 2014
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
4
Review Days
40
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Basic Information
- Device Name
- D-KAT Z-YPE
- K Number
- K142179
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Keeler, Ltd.
- Date Received
- August 8, 2014
- Decision Date
- September 17, 2014
- 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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Other Clearances by Keeler, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | Dec 23, 2013 | Substantially Equivalent |
| K131589 | KEELER SLIT LAMP H-SERIES | Jun 27, 2013 | Substantially Equivalent |
| K093445 | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) | Jan 19, 2010 | Substantially Equivalent |