HL 188 & HL 189 Body Fat Meter
FDA 510(k) K043414 · Health & Life Co., Ltd.
510(k) numberK043414
Submission
- Device name
- HL 188 & HL 189 Body Fat Meter
- Applicant
- Health & Life Co., Ltd.
Flagstaff, AZ, US - Received
- December 13, 2004
- Decision date
- February 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K130311 | Transtek Body Fat AnalyzerMNW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 05/30/2013SE |
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Questions and answers
When was HL 188 & HL 189 Body Fat Meter cleared by the FDA?
HL 188 & HL 189 Body Fat Meter (K043414) received a 510(k) decision of Substantially Equivalent on February 9, 2005, 58 days after the submission was received.
What is the product code of K043414?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.