Glaucoma-Scope
FDA 510(k) K913118 · Ophthalmic Imaging Systems
510(k) numberK913118
Submission
- Device name
- Glaucoma-Scope
- Applicant
- Ophthalmic Imaging Systems
Sacramento, CA, US - Received
- July 15, 1991
- Decision date
- October 9, 1991
- 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 Glaucoma-Scope cleared by the FDA?
Glaucoma-Scope (K913118) received a 510(k) decision of Substantially Equivalent on October 9, 1991, 86 days after the submission was received.
What is the product code of K913118?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.