The following data is part of a premarket notification filed by Hitachi Aloka Medical,ltd. (hitachi Aloka Medical with the FDA for Arietta 60/ariettas60/ariettav60.
| Device ID | K140443 |
| 510k Number | K140443 |
| Device Name: | ARIETTA 60/ARIETTAS60/ARIETTAV60 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| Contact | Angela Vanarsdale |
| Correspondent | Angela Vanarsdale HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04580292774187 | K140443 | 000 |
| 04562122958226 | K140443 | 000 |
| 04562122958141 | K140443 | 000 |
| 04562122951562 | K140443 | 000 |
| 04573596210277 | K140443 | 000 |
| 04573596213988 | K140443 | 000 |