The following data is part of a premarket notification filed by Echolight S.p.a. with the FDA for Echos Family.
| Device ID | K202514 |
| 510k Number | K202514 |
| Device Name: | EchoS Family |
| Classification | Bone Sonometer |
| Applicant | Echolight S.p.A. Via Raffaello Sanzio, 18 Lecce, IT 73100 |
| Contact | Giovanna De Masi |
| Correspondent | Giovanna De Masi Echolight S.p.A. Via Raffaello Sanzio, 18 Lecce, IT 73100 |
| Product Code | MUA |
| CFR Regulation Number | 892.1180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052461860039 | K202514 | 000 |
| 08052461860022 | K202514 | 000 |
| 08052461860046 | K202514 | 000 |