510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K060538Substantially Equivalent

Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911, 8915, 9563 and 9568

Beaverite International Limited, Chevy Chase MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060538 is the FDA 510(k) clearance record for BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568, a class II device, cleared for Beaverite International Limited on under FDA product code MNW (Analyzer, Body Composition). FDA records list one 510(k) clearance for Beaverite International Limited. As of , FDA records show no recalls naming K060538.

Clearance record

Decision date
Received
(224 days to decision)
Product code
MNW Analyzer, Body Composition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Beaverite International Limited 5600 Wisconsin Ave., Chevy Chase MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNW

Trailing 12 months

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

FDA records show no clearances under product code MNW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNW, 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