510(k) K202514
- Device
- EchoS Family
- Applicant
- Echolight S.p.A.
- 510(k) number
- K202514
- Product code
- MUA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-25
- Date received
- 2020-08-31
- Regulation
- 892.1180
- Classification name
- Bone Sonometer
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Giovanna De Masi
- Address
- Via Raffaello Sanzio, 18 Lecce IT 73100 73100
FDA Registration Numbers#
- 3005944888
- 9710602
- 3006701790
- 3015973732
- 3013328880
- 3004977335
Source Documents#
Other 510(k) Records For Product Code MUA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211350 | Bindex BI-2 | Bone Index Finland , Ltd. | 2022-04-29 |
| K180516 | EchoS | Echolight S.P.A | 2018-10-19 |
| K161919 | UltraScan 650 | Cyberlogic, Inc. | 2017-04-05 |
| K161971 | Bindex BI-2 | Bone Index Finland , Ltd. | 2017-01-09 |
| K152020 | Bindex BI-100 | Bone Index Finland , Ltd. | 2016-05-13 |
| K123238 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2013-02-25 |
| K110646 | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER | Beam-Med, Ltd. | 2011-10-12 |
| K103633 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2011-05-11 |
Legacy Summary#
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FDA Review#
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