POLYSTAN HEART-LUNG MACHINE SYSTEM
Device Facts
| Record ID | K894657 |
|---|---|
| Device Name | POLYSTAN HEART-LUNG MACHINE SYSTEM |
| Applicant | Polystan C/O Vitalcor, Inc. |
| Product Code | DJQ · Clinical Toxicology |
| Decision Date | Mar 28, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3670 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A phenothiazine test system is a device intended to measure any of the drugs of the phenothiazine class in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenothiazine use or overdose.
