SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY
Device Facts
| Record ID | K874902 |
|---|---|
| Device Name | SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY |
| Applicant | Gomi Medical Instruments |
| Product Code | BZM · Anesthesiology |
| Decision Date | Jun 7, 1988 |
| 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.
