Ophthalmoscope, Binocular, Indirect
FDA 510(k) K772214 · Varian Assoc., Inc.
510(k) numberK772214
Submission
- Device name
- Ophthalmoscope, Binocular, Indirect
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- December 2, 1977
- Decision date
- December 13, 1977
- 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 Ophthalmoscope, Binocular, Indirect cleared by the FDA?
Ophthalmoscope, Binocular, Indirect (K772214) received a 510(k) decision of Substantially Equivalent on December 13, 1977, 11 days after the submission was received.
What is the product code of K772214?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.