The following data is part of a premarket notification filed by Hitachi Aloka Medical America, Inc. with the FDA for Ust-5550-r; Ust-5536-r; L43k.
| Device ID | K152126 |
| 510k Number | K152126 |
| Device Name: | UST-5550-R; UST-5536-R; L43K |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HITACHI ALOKA MEDICAL AMERICA, INC. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -5903 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale HITACHI ALOKA MEDICAL AMERICA, INC. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -5903 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2016-08-17 |
| Summary: | summary |