Model #12000 Binocular Inderect Ophthalmoscope
FDA 510(k) K930023 · Welch Allyn, Inc.
510(k) numberK930023
Submission
- Device name
- Model #12000 Binocular Inderect Ophthalmoscope
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- January 5, 1993
- Decision date
- June 21, 1993
- 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 Model #12000 Binocular Inderect Ophthalmoscope cleared by the FDA?
Model #12000 Binocular Inderect Ophthalmoscope (K930023) received a 510(k) decision of Substantially Equivalent on June 21, 1993, 167 days after the submission was received.
What is the product code of K930023?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.