Tanita Segmental Body Composition Analyzer, Model BC-418
FDA 510(k) K033157 · Tanita Corp. of America
510(k) numberK033157
Submission
- Device name
- Tanita Segmental Body Composition Analyzer, Model BC-418
- Applicant
- Tanita Corp. of America
Arlington Heights, IL, US - Received
- September 30, 2003
- Decision date
- April 8, 2004
- 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
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 |
|---|---|---|
| K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)MNW · Traditional | 12/23/2004SE |
| K040978 | Tanita Scale Plus Body Fat Monitor with Body Water PercentageMNW · Traditional | 07/22/2004SE |
| K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleMNW · Traditional | 06/24/2002SE |
| K930599 | Body Fat Analyzer Model TBF-105DSB · Traditional | 11/01/1994SE |
| K932572 | Digital Baby Scale Model BLB-12FRW · Traditional | 11/16/1993SE |
Questions and answers
When was Tanita Segmental Body Composition Analyzer, Model BC-418 cleared by the FDA?
Tanita Segmental Body Composition Analyzer, Model BC-418 (K033157) received a 510(k) decision of Substantially Equivalent on April 8, 2004, 191 days after the submission was received.
What is the product code of K033157?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.