Retina Flowmeter
FDA 510(k) K943955 · Heidelberg Engineering
510(k) numberK943955
Submission
- Device name
- Retina Flowmeter
- Applicant
- Heidelberg Engineering
D06900 Heidelberg,Germany, DE - Received
- August 15, 1994
- Decision date
- November 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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Questions and answers
When was Retina Flowmeter cleared by the FDA?
Retina Flowmeter (K943955) received a 510(k) decision of Substantially Equivalent on November 14, 1994, 91 days after the submission was received.
What is the product code of K943955?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.