K865084 is an FDA 510(k) clearance for the AMICI XENON REBREATHING SYSTEM*. This device is classified as a System, Rebreathing, Radionuclide (Class II - Special Controls, product code IYT).
Submitted by Amici, Inc. (Royersford, US). The FDA issued a Cleared decision on March 3, 1987, 63 days after receiving the submission on December 30, 1986.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1390.
| 510(k) Number | K865084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1986 |
| Decision Date | March 03, 1987 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IYT — System, Rebreathing, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1390 |