Data / Medical devices / United States / Cortex Metabolic Inc.
Cortex Metabolic Inc.: FDA-registered device maker in Eatonton, GA, United States, 2 510(k) clearances
Cortex Metabolic Inc. is registered with the FDA (registration 3037873864) in Eatonton, GA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 22, 2001. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3037873864
- Address
- 126 Cuscowilla Dr, Eatonton, GA, United States, 31024
- Owner or operator
- CORTEX MetaBolic Inc. (10095608)
- Roles
- Complaint file establishment
- First device listed
- April 2, 2026
- Registered through
- 2027
- Brand names listed
- MetaLyzer; MetaLyzer 3B; MetaSoft; MetaSoft Studio, MetaMax; MetaMax 3B; MetaSoft; MetaSoft Studio
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Predicted Values, Pulmonary Function | BTY | 2 | Complaint file establishment | accessdata.fda.gov |
| Calculator, Pulmonary Function Data | BZC | 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 |
|---|---|---|---|---|---|---|
| February 22, 2001 | K001631 | CORTEX METAMAX | BZC | Substantially Equivalent | Cortex Biophysik GmbH | accessdata.fda.gov |
| December 14, 2000 | K993641 | METALYZER, MODEL 2; METALYZER, MODEL 3 | BTY | Substantially Equivalent | Cortex Biophysik GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Calculator, Pulmonary Function Data
- All makers of Calculator, Predicted Values, Pulmonary Function
Updated February 22, 2001. 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.