Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514
FDA 510(k) K122388 · Seca GmbH & Co. KG
510(k) numberK122388
Submission
- Device name
- Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514
- Applicant
- Seca GmbH & Co. KG
Washington, DC, US - Received
- August 6, 2012
- Decision date
- May 2, 2013
- 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.
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| K192092 | Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535DXN · Traditional | 01/23/2020SE |
| K822135 | Seca Digital Baby Scale 727FRW · Traditional | 07/30/1982SE |
| K822043 | Seca Chair SCALE-721FRW · Traditional | 07/28/1982SE |
| K822042 | Seca Light Weight Baby Scale 744FRW · Traditional | 07/28/1982SE |
Questions and answers
When was Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514 cleared by the FDA?
Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514 (K122388) received a 510(k) decision of Substantially Equivalent on May 2, 2013, 269 days after the submission was received.
What is the product code of K122388?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.