510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861905Substantially Equivalent

Plotter Model (Mp100)

Madsen Electronics (Canada), Ltd., Oakville, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861905 is the FDA 510(k) clearance record for PLOTTER MODEL (MP100), cleared for Madsen Electronics (Canada) , Ltd. on . FDA records list 17 510(k) clearances for Madsen Electronics (Canada) , Ltd., from to . As of , FDA records show no recalls naming K861905.

Clearance record

Decision date
Received
(194 days to decision)
Review panel
Unknown
Applicant
Madsen Electronics (Canada) , Ltd. 2370 Speers Rd., Oakville, Ontario, CA
Third party review
No