Submission Details
| 510(k) Number | K081557 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 2008 |
| Decision Date | September 10, 2008 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
K081557 is an FDA 510(k) clearance for the PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER, a Cassette, Radiographic Film (Class II — Special Controls, product code IXA), submitted by Jddb Manufacturing, Inc. (Riverdale, US). The FDA issued a Cleared decision on September 10, 2008, 99 days after receiving the submission on June 3, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1850.
| 510(k) Number | K081557 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 2008 |
| Decision Date | September 10, 2008 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXA — Cassette, Radiographic Film |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1850 |