The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Ust-5258-5 Diagnostic Ultrasound Transducer.
| Device ID | K964549 |
| 510k Number | K964549 |
| Device Name: | ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Paul D Smolenski |
| Correspondent | Paul D Smolenski ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-13 |
| Decision Date | 1997-06-03 |
| Summary: | summary |