Data / Medical devices / United States / Biospace Inc.
Biospace Inc.: FDA-registered device maker in Cerritos, CA, United States, 3 510(k) clearances
Biospace Inc. is registered with the FDA (registration 3003193933) in Cerritos, CA, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 23, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003193933
- Address
- 13850 Cerritos Corporate DR Ste C, Cerritos, CA, United States, 90703
- Owner or operator
- InBody Co. Ltd. (9041413)
- Roles
- Complaint file establishment
- First device listed
- November 8, 2010
- Registered through
- 2027
- Brand names listed
- BPBIO 320 S, BPBIO 320 SN, BPBIO 330 S, BPBIO 330 SN, BPBIO 750, BPBIO320, BPBIO320n, BPBIO680KV and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Complaint file establishment | accessdata.fda.gov |
| Analyzer, Body Composition, Exempt | PUH | 2 | Complaint file establishment | accessdata.fda.gov |
| Ataxiagraph | GWW | 1 | Complaint file establishment | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment | accessdata.fda.gov |
| Platform, Force-Measuring | KHX | 1 | Complaint file establishment | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Isokinetic Testing And Evaluation | IKK | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2014 | K141483 | BIOSPACE BODY COMPOSITION ANALYZER | MNW | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
| November 25, 2013 | K130777 | INBODY | MNW | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
| September 4, 2013 | K131064 | BIOSPACE | DXN | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition
- All makers of System, Isokinetic Testing And Evaluation
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Non-Surgical Gown
- All makers of Scale, Patient
Updated September 23, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.