Submission Details
| 510(k) Number | K840385 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 30, 1984 |
| Decision Date | February 27, 1984 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
K840385 is an FDA 510(k) clearance for the VIDEO PRINT, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Advanced Instruments, Inc.. The FDA issued a Cleared decision on February 27, 1984, 28 days after receiving the submission on January 30, 1984. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.
| 510(k) Number | K840385 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 30, 1984 |
| Decision Date | February 27, 1984 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | LMC — Camera, Multi Format, Radiological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.2040 |