510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Echosens

Paris Paris, FR

ECHOSENS appears in FDA device records in Paris Paris, FR. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Echosens between 2013 and 2023. The busiest year on record is 2015, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Echosens, by decision year
YearClearances
20131
20152
20161
20172
20181
20201
20212
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)IYOSubstantially Equivalent
K212035FibroScan 230IYOSubstantially Equivalent
K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)IYOSubstantially Equivalent
K200655FibroScan® 630IYOSubstantially Equivalent
K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)IYOSubstantially Equivalent
K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)IYOSubstantially Equivalent
K172142FibroScan 430 Mini+IYOSubstantially Equivalent
K160524FibroScan 530 CompactIYOSubstantially Equivalent
K150239FibroScanIYOSubstantially Equivalent
K150949FibroScanIYOSubstantially Equivalent
K123806FIBROSCANIYOSubstantially Equivalent

Registered establishments

FDA registered establishments for Echosens, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30102584563010258456ECHOSENS6 rue Ferrus, Paris 75014 FR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain