The following data is part of a premarket notification filed by Hitachi Aloka Medical, Ltd. with the FDA for Prosound F75 Diagnostic Ultrasound System.
| Device ID | K140639 |
| 510k Number | K140639 |
| Device Name: | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. Wallingford Ct, CT 06492 -7502 |
| Contact | Angela Vanarsdale |
| Correspondent | Angela Vanarsdale HITACHI ALOKA MEDICAL, LTD. 10 FAIRFIELD BLVD. Wallingford Ct, 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 | 2014-03-12 |
| Decision Date | 2014-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122958578 | K140639 | 000 |
| 04562122958561 | K140639 | 000 |
| 04562122958295 | K140639 | 000 |
| 04562122958288 | K140639 | 000 |
| 04562122958073 | K140639 | 000 |
| 04562122957946 | K140639 | 000 |
| 04562122957199 | K140639 | 000 |
| 04562122957182 | K140639 | 000 |
| 04562122956185 | K140639 | 000 |