FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EDI VERIS SYSTEM
K Number: K983983
·
Decision Feb 3, 1999
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
17
Applicant Total
2
Review Days
86
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Basic Information
- Device Name
- EDI VERIS SYSTEM
- K Number
- K983983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1630
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electro-Diagnostic Imaging, Inc.
- Date Received
- November 9, 1998
- Decision Date
- February 3, 1999
- Product Code
- HLX
- 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 |
|---|---|---|---|
| HLX | Photostimulator, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Electro-Diagnostic Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003442 | MODIFICATION TO EDI VERIS SYSTEM | May 4, 2001 | Substantially Equivalent |