Macular Function Analyzer
FDA 510(k) K843227 · Danek Medical, Inc.
510(k) numberK843227
Submission
- Device name
- Macular Function Analyzer
- Applicant
- Danek Medical, Inc.
Walker, MI, US - Received
- August 16, 1984
- Decision date
- July 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOQ – Grid, Amsler
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1330
- Specialty
- Ophthalmic
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Questions and answers
When was Macular Function Analyzer cleared by the FDA?
Macular Function Analyzer (K843227) received a 510(k) decision of Substantially Equivalent on July 22, 1985, 340 days after the submission was received.
What is the product code of K843227?
The FDA product code is HOQ – Grid, Amsler, a Class I (low risk) device regulated under 21 CFR 886.1330.