Body Fat Analyzer, Model HBF-306
FDA 510(k) K011652 · Omron Healthcare, Inc.
510(k) numberK011652
Submission
- Device name
- Body Fat Analyzer, Model HBF-306
- Applicant
- Omron Healthcare, Inc.
Vernon Hills, IL, US - Received
- May 29, 2001
- Decision date
- November 7, 2001
- 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 Body Fat Analyzer, Model HBF-306 cleared by the FDA?
Body Fat Analyzer, Model HBF-306 (K011652) received a 510(k) decision of Substantially Equivalent on November 7, 2001, 162 days after the submission was received.
What is the product code of K011652?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.