Professional Indirect Ophthalmoscope
FDA 510(k) K912397 · Clement Clarke, Inc.
510(k) numberK912397
Submission
- Device name
- Professional Indirect Ophthalmoscope
- Applicant
- Clement Clarke, Inc.
England, GB - Received
- May 28, 1991
- Decision date
- October 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Professional Indirect Ophthalmoscope cleared by the FDA?
Professional Indirect Ophthalmoscope (K912397) received a 510(k) decision of Substantially Equivalent on October 23, 1991, 148 days after the submission was received.
What is the product code of K912397?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.