510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K834501Substantially Equivalent

Angioscane Spectrum Analyzer

Unigon Industries, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834501 is the FDA 510(k) clearance record for ANGIOSCANE SPECTRUM ANALYZER, cleared for Unigon Industries, Inc. on . FDA records list 3 510(k) clearances for Unigon Industries, Inc., from to . As of , FDA records show no recalls naming K834501.

Clearance record

Decision date
Received
(154 days to decision)
Review panel
Unknown
Applicant
Unigon Industries, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No