510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K030349Substantially Equivalent

Healthometer Professional Body Fat Monitor and Scale, Models Bfm 940, Bfm 945 & Bfm 960

Bonso Electronics International, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030349 is the FDA 510(k) clearance record for HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960, a class II device, cleared for Bonso Electronics International, Inc. on under FDA product code MNW (Analyzer, Body Composition). FDA records list one 510(k) clearance for Bonso Electronics International, Inc. As of , FDA records show no recalls naming K030349.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MNW Analyzer, Body Composition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Bonso Electronics International, Inc. 719 A St. NE, Washington DC
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