Model 5400 Optokinetic Stimulator
FDA 510(k) K822917 · Life-Tech Intl., Inc.
510(k) numberK822917
Submission
- Device name
- Model 5400 Optokinetic Stimulator
- Applicant
- Life-Tech Intl., Inc.
Mchenry, IL, US - Received
- October 1, 1982
- Decision date
- November 1, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOW – Drum, Opticokinetic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1200
- Specialty
- Ophthalmic
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Questions and answers
When was Model 5400 Optokinetic Stimulator cleared by the FDA?
Model 5400 Optokinetic Stimulator (K822917) received a 510(k) decision of Substantially Equivalent on November 1, 1982, 31 days after the submission was received.
What is the product code of K822917?
The FDA product code is HOW – Drum, Opticokinetic, a Class I (low risk) device regulated under 21 CFR 886.1200.