The following data is part of a premarket notification filed by Interson Corp. with the FDA for Interson Transrectal Probe/kontron Ultrasound Syst.
| Device ID | K911113 |
| 510k Number | K911113 |
| Device Name: | INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | INTERSON CORP. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook INTERSON CORP. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-07 |
| Decision Date | 1991-12-17 |