Monocular Direct Ophthalmoscope
FDA 510(k) K844971 · Nidek, Inc.
510(k) numberK844971
Submission
- Device name
- Monocular Direct Ophthalmoscope
- Applicant
- Nidek, Inc.
Palo Alto, CA, US - Received
- December 24, 1984
- Decision date
- February 15, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Monocular Direct Ophthalmoscope cleared by the FDA?
Monocular Direct Ophthalmoscope (K844971) received a 510(k) decision of Substantially Equivalent on February 15, 1985, 53 days after the submission was received.
What is the product code of K844971?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.