FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
K Number: K131787
·
Decision Dec 23, 2013
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
4
Review Days
188
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Basic Information
- Device Name
- CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
- K Number
- K131787
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.4170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Keeler, Ltd.
- Date Received
- June 18, 2013
- Decision Date
- December 23, 2013
- Product Code
- HRN
- 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 |
|---|---|---|---|
| HRN | Unit, Cryophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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