The following data is part of a premarket notification filed by Hitachi Aloka Medical, Ltd. with the FDA for Intra-operative Ultrasound Transducer.
| Device ID | K140854 |
| 510k Number | K140854 |
| Device Name: | INTRA-OPERATIVE ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| Contact | Angela Vanarsdale |
| Correspondent | Angela Vanarsdale HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04573596212691 | K140854 | 000 |