BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
Device Facts
| Record ID | K862123 |
|---|---|
| Device Name | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE |
| Applicant | Marion Laboratories, Inc. |
| Product Code | KZJ · Microbiology |
| Decision Date | Jun 16, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2580 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A gas-generating device is a device intended for medical purposes that produces predetermined amounts of selected gases to be used in a closed chamber in order to establish suitable atmospheric conditions for cultivation of microorganisms with special atmospheric requirements. The device aids in the diagnosis of disease.
