510(k) K822917
- Device
- MODEL 5400 OPTOKINETIC STIMULATOR
- Applicant
- LIFE-TECH INTL., INC.
- 510(k) number
- K822917
- Product code
- HOW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-01
- Date received
- 1982-10-01
- Regulation
- 886.1200
- Classification name
- Drum, Opticokinetic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3042228518
- 1820463
- 9710334
- 2518410
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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