Omron Fat Loss Monitor with Scale, Model HBF-400
FDA 510(k) K043060 · Omron Healthcare, Inc.
510(k) numberK043060
Submission
- Device name
- Omron Fat Loss Monitor with Scale, Model HBF-400
- Applicant
- Omron Healthcare, Inc.
Bonita Springs, FL, US - Received
- November 5, 2004
- Decision date
- January 19, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MNW – Analyzer, Body Composition
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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Questions and answers
When was Omron Fat Loss Monitor with Scale, Model HBF-400 cleared by the FDA?
Omron Fat Loss Monitor with Scale, Model HBF-400 (K043060) received a 510(k) decision of Substantially Equivalent on January 19, 2005, 75 days after the submission was received.
What is the product code of K043060?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.