510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K834525Substantially Equivalent

Angioscan Flo Mad Spectrum Analyzer

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

K834525 is the FDA 510(k) clearance record for ANGIOSCAN FLO MAD SPECTRUM ANALYZER, a class II device, cleared for Unigon Industries, Inc. on under FDA product code JOP (Transducer, Ultrasonic). FDA records list 3 510(k) clearances for Unigon Industries, Inc., from to . As of , FDA records show no recalls naming K834525.

Clearance record

Decision date
Received
(154 days to decision)
Product code
JOP Transducer, Ultrasonic
Regulation
21 CFR 870.2880
Device class
Class II
Review panel
Cardiovascular
Applicant
Unigon Industries, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JOP

Trailing 12 months

FDA records hold no clearances under product code JOP in the trailing twelve months.

FDA records show no clearances under product code JOP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260