The following data is part of a premarket notification filed by Hitachi Aloka Medical, Ltd. with the FDA for Noblus Ultrasound Diagnostic System.
| Device ID | K130308 |
| 510k Number | K130308 |
| Device Name: | NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| 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 | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2013-04-05 |
| Summary: | summary |