510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K837353Substantially Equivalent

Floatex Ls-22

Elscint, Inc., Hackensack NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837353 is the FDA 510(k) clearance record for FLOATEX LS-22, cleared for Elscint, Inc. on . FDA records list 94 510(k) clearances for Elscint, Inc., from to . As of , FDA records show no recalls naming K837353.

Clearance record

Decision date
Received
(9 days to decision)
Review panel
Unknown
Applicant
Elscint, Inc. 505 Main St., Hackensack NJ
Third party review
No