FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ETV, ELECTRONIC VISION AID
K Number: K884540
·
Decision Jan 19, 1989
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
0
Applicant Total
2
Review Days
83
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Basic Information
- Device Name
- ETV, ELECTRONIC VISION AID
- K Number
- K884540
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5915
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Sevrain-Tech, Inc.
- Date Received
- October 28, 1988
- Decision Date
- January 19, 1989
- Product Code
- HPE
- 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 |
|---|---|---|---|
| HPE | Aid, Vision, Optical, Battery-Powered | FDA class 1 | Ophthalmic |
Other Clearances by Sevrain-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883853 | ETA | Nov 17, 1988 | Substantially Equivalent |