FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
K Number: K040913
·
Decision Jul 23, 2004
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
10
Review Days
106
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Basic Information
- Device Name
- NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
- K Number
- K040913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch & Lomb
- Date Received
- April 8, 2004
- Decision Date
- July 23, 2004
- Product Code
- MXK
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXK | Device, Analysis, Anterior Segment | FDA class 2 | Ophthalmic |
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