The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for 6450 Ultrasound System.
| Device ID | K192157 |
| 510k Number | K192157 |
| Device Name: | 6450 Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Esaote, S.p.A. Via E Melen 77 Genoa, IT 16152 |
| Contact | Piet Dejong |
| Correspondent | Piet Dejong Esaote, S.p.A. Via E Melen 77 Genoa, IT 16152 |
| 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 | 2019-08-09 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304455628 | K192157 | 000 |