510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850870Substantially Equivalent

Medifette Ergometer

Ketronic, Inc., The Netherlands, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850870 is the FDA 510(k) clearance record for MEDIFETTE ERGOMETER, cleared for Ketronic, Inc. on . FDA records list 10 510(k) clearances for Ketronic, Inc., from to . As of , FDA records show no recalls naming K850870.

Clearance record

Decision date
Received
(103 days to decision)
Review panel
Unknown
Applicant
Ketronic, Inc. Duinkerkenlaan 31, The Netherlands, NL
Third party review
No