The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for A-scan Roll-around Stand.
| Device ID | K900161 |
| 510k Number | K900161 |
| Device Name: | A-SCAN ROLL-AROUND STAND |
| Classification | Stand, Instrument, Ophthalmic, Non-powered |
| Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Product Code | HMG |
| CFR Regulation Number | 886.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-12 |
| Decision Date | 1990-02-16 |