The following data is part of a premarket notification filed by Hitachi, Ltd. with the FDA for Aloka Lisendo 880.
| Device ID | K162583 |
| 510k Number | K162583 |
| Device Name: | ALOKA LISENDO 880 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI, LTD. 10 FAIRFIELD BLVD Wallingford, CT 06492 -5903 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale HITACHI, LTD. 10 FAIRFIELD BLVD Wallingford, CT 06492 -5903 |
| 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 | 2016-09-15 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122959162 | K162583 | 000 |
| 04573596212202 | K162583 | 000 |
| 04573596212257 | K162583 | 000 |
| 04573596214152 | K162583 | 000 |
| 04562122958851 | K162583 | 000 |
| 04562122958868 | K162583 | 000 |
| 04562122958875 | K162583 | 000 |
| 04562122958882 | K162583 | 000 |
| 04562122958967 | K162583 | 000 |
| 04573596212196 | K162583 | 000 |