K913416 is an FDA 510(k) clearance for the TETLEY PATIENT ADMINISTRATION SET. This device is classified as a System, Rebreathing, Radionuclide (Class II — Special Controls, product code IYT).
Submitted by Tetley Medical , Ltd. (Simi Valley, US). The FDA issued a Cleared decision on October 28, 1991, 89 days after receiving the submission on July 31, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1390.
| 510(k) Number | K913416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1991 |
| Decision Date | October 28, 1991 |
| Days to Decision | 89 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 |