Biodynamics Bia 500 Biompedance Body Composition Analyzer
FDA 510(k) K051675 · Biodynamics Corp.
510(k) numberK051675
Submission
- Device name
- Biodynamics Bia 500 Biompedance Body Composition Analyzer
- Applicant
- Biodynamics Corp.
Seattle, WA, US - Received
- June 23, 2005
- Decision date
- March 16, 2006
- 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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| K141483 | Biospace Body Composition AnalyzerMNW · Traditional | Biospace Corporation Limited | 09/23/2014SE |
| K133872 | Aria Wifi Smart ScaleMNW · Traditional | Fitbit, Inc. | 06/02/2014SE |
| K140594 | Body Fat Analyzer and ScaleMNW · Traditional | Conmo Electronic Company Limited | 05/30/2014SE |
| K130856 | Bia / Vitality AnalyzerMNW · Traditional | Ipgdx, LLC | 11/25/2013SE |
| K130777 | InbodyMNW · Traditional | Biospace Corporation Limited | 11/25/2013SE |
| K130952 | Precision One Lifecare; Detecto; DetectoMNW · Traditional | Precision One Lifecare, Ltd. | 09/26/2013SE |
| K131394 | Transtek Glass Body Fat AnalyzerMNW · Special | Guangdong Transtek Medical Electronics Co., Ltd. | 09/18/2013SE |
| K130311 | Transtek Body Fat AnalyzerMNW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 05/30/2013SE |
More from Guangdong Transtek Medical Electronics Co., Ltd.
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| K881968 | Biodynamics Model BI-400 Body Composition AnalyzerDSB · Traditional | 07/28/1988SE |
| K874361 | Biodynamics Model BI-300 Body Composition AnalyzerDSB · Traditional | 03/16/1988SE |
| K873807 | Autotransfusion ApparatusCAC · Traditional | 03/09/1988SE |
| K874034 | ADR-22 Automatic Dialyzer ReprocessorLIF · Traditional | 10/23/1987SE |
| K870052 | Infumix Mixing ContainerKPE · Traditional | 02/27/1987SE |
| K822716 | Universal CentrifugeJPI · Traditional | 09/30/1982SE |
| K822715 | Platelet CentrifugeJQC · Traditional | 09/30/1982SE |
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Questions and answers
When was Biodynamics Bia 500 Biompedance Body Composition Analyzer cleared by the FDA?
Biodynamics Bia 500 Biompedance Body Composition Analyzer (K051675) received a 510(k) decision of Substantially Equivalent on March 16, 2006, 266 days after the submission was received.
What is the product code of K051675?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.