K930357 is an FDA 510(k) clearance for the ACCESSORY TO UNIVERSAL OCTOPAQUE. This device is classified as a Cradle, Patient, Radiologic (Class I - General Controls, product code KXH).
Submitted by Octostop, Inc. (Montreal, Qc., CA). The FDA issued a Cleared decision on July 13, 1993, 168 days after receiving the submission on January 26, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1830.
| 510(k) Number | K930357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1993 |
| Decision Date | July 13, 1993 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KXH — Cradle, Patient, Radiologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1830 |