Bodystat 1500MDD Body Composition Monitoring Unit
FDA 510(k) K994242 · Bodystat , Ltd.
510(k) numberK994242
Submission
- Device name
- Bodystat 1500MDD Body Composition Monitoring Unit
- Applicant
- Bodystat , Ltd.
British Isles, BR - Received
- December 16, 1999
- Decision date
- March 15, 2000
- 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
Other 510(k)s with product code MNW
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| K231116 | Multi-parameter detectorMNW · Traditional | Zhongshan Jinli Electronic Weighing Equipment… | 06/15/2024SE |
| K140045 | Body Composition AnalyzerMNW · Traditional | Jawon Medical Co., Ltd. | 02/18/2015SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K082255 | Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental Monitoring UnitMNW · Traditional | 02/07/2011SE |
| K082254 | Modification to Bodystat 1500MDD Body Composition Monitoring UnitMNW · Traditional | 02/07/2011SE |
| K082253 | Bodystat 1500 Body Composition Monitoring UnitMNW · Traditional | 11/25/2008SE |
| K002835 | BodystatMNW · Traditional | 07/03/2001SE |
| K980971 | Bodystat Dualscan 2005MNW · Traditional | 06/11/1998SE |
| K971554 | BodystatMNW · Traditional | 11/26/1997SE |
| K951097 | BodystayDSB · Traditional | 11/22/1995SE |
Questions and answers
When was Bodystat 1500MDD Body Composition Monitoring Unit cleared by the FDA?
Bodystat 1500MDD Body Composition Monitoring Unit (K994242) received a 510(k) decision of Substantially Equivalent on March 15, 2000, 90 days after the submission was received.
What is the product code of K994242?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.