SPIROMETRICS MODEL 2500 FLOWMATE(TM)
Device Facts
| Record ID | K863953 |
|---|---|
| Device Name | SPIROMETRICS MODEL 2500 FLOWMATE(TM) |
| Applicant | Spirometrics, Inc. |
| Product Code | BZM · Anesthesiology |
| Decision Date | Jan 15, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.