The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Arietta 750.
| Device ID | K191233 |
| 510k Number | K191233 |
| Device Name: | ARIETTA 750 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Aaron Pierce |
| Correspondent | Aaron Pierce Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| 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 | 2019-05-08 |
| Decision Date | 2019-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122959841 | K191233 | 000 |
| 04573596214008 | K191233 | 000 |
| 04573596212318 | K191233 | 000 |