Propper Insight Binocular Indirect Ophthalmosope
FDA 510(k) K141638 · Propper Manufacturing Co., Inc.
510(k) numberK141638
Submission
- Device name
- Propper Insight Binocular Indirect Ophthalmosope
- Applicant
- Propper Manufacturing Co., Inc.
Long Island, NY, US - Received
- June 19, 2014
- Decision date
- September 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Propper Insight Binocular Indirect Ophthalmosope cleared by the FDA?
Propper Insight Binocular Indirect Ophthalmosope (K141638) received a 510(k) decision of Substantially Equivalent on September 17, 2014, 90 days after the submission was received.
What is the product code of K141638?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.