K812893 is an FDA 510(k) clearance for the SUPERFLAB. This device is classified as a Phantom, Anthropomorphic, Nuclear (Class I - General Controls, product code IYP).
Submitted by Mick Radio-Nuclear Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1981, 54 days after receiving the submission on October 15, 1981.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1370.
| 510(k) Number | K812893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1981 |
| Decision Date | December 08, 1981 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IYP — Phantom, Anthropomorphic, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1370 |