The following data is part of a premarket notification filed by Interson Corp. with the FDA for Interson Multiplane Rectal Probe For Aloka Ultra..
| Device ID | K900555 |
| 510k Number | K900555 |
| Device Name: | INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA. |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | INTERSON CORP. 7068 KOLL CENTER PKWY., #415 Pleasanton, CA 94566 |
| Contact | Mark F Hayward |
| Correspondent | Mark F Hayward INTERSON CORP. 7068 KOLL CENTER PKWY., #415 Pleasanton, CA 94566 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-06 |
| Decision Date | 1990-05-02 |