Friedmann Analyser 3
FDA 510(k) K914896 · Clement Clarke, Inc.
510(k) numberK914896
Submission
- Device name
- Friedmann Analyser 3
- Applicant
- Clement Clarke, Inc.
England, GB - Received
- October 31, 1991
- Decision date
- January 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HOK – Screen, Tangent, Projection, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1810
- Specialty
- Ophthalmic
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Questions and answers
When was Friedmann Analyser 3 cleared by the FDA?
Friedmann Analyser 3 (K914896) received a 510(k) decision of Substantially Equivalent on January 23, 1992, 84 days after the submission was received.
What is the product code of K914896?
The FDA product code is HOK – Screen, Tangent, Projection, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1810.