FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRO2, HS-75
K Number: K011914
·
Decision Jul 27, 2001
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
117
Applicant Total
6
Review Days
38
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Basic Information
- Device Name
- HYDRO2, HS-75
- K Number
- K011914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innovision, Inc.
- Date Received
- June 19, 2001
- Decision Date
- July 27, 2001
- Product Code
- HQD
- 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 |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | FDA class 2 | Ophthalmic |
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Other Clearances by Innovision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151146 | N-Force Fixation System | Jul 24, 2015 | Substantially Equivalent |
| K132244 | N-FORCE FIXATION SYSTEM | Mar 6, 2014 | Substantially Equivalent |
| K102528 | N-FORCE FIXATION SYSTEM | Jul 28, 2011 | Substantially Equivalent |
| K000485 | HYDRO2, HS-75 | May 12, 2000 | Substantially Equivalent |
| K944223 | ACCUCON | Dec 7, 1994 | Substantially Equivalent |