FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EnFocus 2300, EnFocus 4400
K Number: K150722
·
Decision Dec 2, 2015
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
86
Applicant Total
4
Review Days
257
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Basic Information
- Device Name
- EnFocus 2300, EnFocus 4400
- K Number
- K150722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioptigen, Inc.
- Date Received
- March 20, 2015
- Decision Date
- December 2, 2015
- Product Code
- HLI
- 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 |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | FDA class 2 | Ophthalmic |
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