K200916 is an FDA 510(k) clearance for the Patient Administration Set. This device is classified as a System, Rebreathing, Radionuclide (Class II - Special Controls, product code IYT).
Submitted by Cyclomedica Australia Pty, Ltd. (Kingsgrove, AU). The FDA issued a Cleared decision on September 1, 2020, 148 days after receiving the submission on April 6, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1390.
| 510(k) Number | K200916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2020 |
| Decision Date | September 01, 2020 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYT - System, Rebreathing, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1390 |