Neitz Halogen Binocular Indirect Ophthalmoscope Io-A
FDA 510(k) K942712 · Neitz Instruments Company, Ltd.
510(k) numberK942712
Submission
- Device name
- Neitz Halogen Binocular Indirect Ophthalmoscope Io-A
- Applicant
- Neitz Instruments Company, Ltd.
Washington, DC, US - Received
- June 9, 1994
- Decision date
- August 5, 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 Neitz Halogen Binocular Indirect Ophthalmoscope Io-A cleared by the FDA?
Neitz Halogen Binocular Indirect Ophthalmoscope Io-A (K942712) received a 510(k) decision of Substantially Equivalent on August 5, 1994, 57 days after the submission was received.
What is the product code of K942712?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.