510(k) K884540
- Device
- ETV, ELECTRONIC VISION AID
- Applicant
- SEVRAIN-TECH, INC.
- 510(k) number
- K884540
- Product code
- HPE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-19
- Date received
- 1988-10-28
- Regulation
- 886.5915
- Classification name
- Aid, Vision, Optical, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HEATHER R SCHRAMM
- Address
- Park Centre 8025 Excelsior Dr., Suite 1 Madison WI US 53717 53717
FDA Registration Numbers#
- 1123650
- 3004571972
- 3015257463
- 3015769026
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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