PB100 DIAGNOSTIC SPIROMETER
Device Facts
| Record ID | K911143 |
|---|---|
| Device Name | PB100 DIAGNOSTIC SPIROMETER |
| Applicant | Puritan Bennett Corp. |
| Product Code | BZM · Anesthesiology |
| Decision Date | Nov 29, 1991 |
| 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.