K141638 is an FDA 510(k) clearance for the PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE. This device is classified as a Ophthalmoscope, Ac-powered (Class II - Special Controls, product code HLI).
Submitted by Propper Manufacturing Co., Inc. (Long Island, US). The FDA issued a Cleared decision on September 17, 2014, 90 days after receiving the submission on June 19, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K141638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2014 |
| Decision Date | September 17, 2014 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HLI - Ophthalmoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |