The following data is part of a premarket notification filed by Echolight S.p.a with the FDA for Echosk And Echosgyn Modules For Echos Family Devices.
| Device ID | K212851 |
| 510k Number | K212851 |
| Device Name: | EchoSK And EchoSGyn Modules For EchoS Family Devices |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Echolight S.p.A Via Raffaello Sanzio, 18 Lecce, IT 73100 |
| Contact | Giuseppe Criscenti |
| Correspondent | Giuseppe Criscenti Echolight S.p.A Via Raffaello Sanzio, 18 Lecce, IT 73100 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2022-03-16 |