BIOSPACE BODY COMPOSITION ANALYZER
FDA 510(k) clearance K141483 · decided 2014-09-23
Clearance details
- K-number
- K141483
- Device name
- BIOSPACE BODY COMPOSITION ANALYZER
- Applicant
- Biospace Corporation Limited
- Decision
- Substantially Equivalent
- Date received
- 2014-06-05
- Decision date
- 2014-09-23
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- MNW
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Naples, FL, US
- Third-party review
- No
- Expedited review
- No
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| INBODY (K130777) | Biospace Corporation Limited | 2013-11-25 |
| BIA / VITALITY ANALYZER (K130856) | Ipgdx, LLC | 2013-11-25 |
| PRECISION ONE LIFECARE; DETECTO; DETECTO (K130952) | Precision One Lifecare, Ltd. | 2013-09-26 |
| TRANSTEK GLASS BODY FAT ANALYZER (K131394) | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-09-18 |
| TRANSTEK BODY FAT ANALYZER (K130311) | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-05-30 |
| SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 (K122388) | Seca GmbH & Co. KG | 2013-05-02 |
| INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) (K123228) | Biospace Corporation Limited | 2013-03-08 |
| TRANSTEK GLASS BODY FAT ANALYZER (K123781) | Zhongshan Transtek Electronics Co., Ltd. | 2013-01-09 |
Recalls involving this device
No recalls on record reference this clearance.