K980402 is an FDA 510(k) clearance for the CAPINTEC MODEL 292 ELECTROMETER. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Capintec, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on April 24, 1998, 81 days after receiving the submission on February 2, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K980402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1998 |
| Decision Date | April 24, 1998 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |