K897098 is an FDA 510(k) clearance for the SIEMENS ENDO-P-PROBE. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Siemens Medical Solutions USA, Inc. (San Ramon, US). The FDA issued a Cleared decision on February 23, 1990, 64 days after receiving the submission on December 21, 1989.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K897098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1989 |
| Decision Date | February 23, 1990 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |