K900161 is an FDA 510(k) clearance for the A-SCAN ROLL-AROUND STAND. This device is classified as a Stand, Instrument, Ophthalmic, Non-powered (Class I - General Controls, product code HMG).
Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on February 16, 1990, 35 days after receiving the submission on January 12, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1860.
| 510(k) Number | K900161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 1990 |
| Decision Date | February 16, 1990 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HMG — Stand, Instrument, Ophthalmic, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1860 |