K915340 is an FDA 510(k) clearance for the MENTOR HORIZON LOW VISION MAGNIFIER. This device is classified as a System, Reading, Television, Closed-circuit (Class I - General Controls, product code HJG).
Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on March 30, 1992, 158 days after receiving the submission on October 24, 1991.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5820.
| 510(k) Number | K915340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 1991 |
| Decision Date | March 30, 1992 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HJG — System, Reading, Television, Closed-circuit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5820 |