DX1-PORTABLE
Device Facts
| Record ID | K951157 |
|---|---|
| Device Name | DX1-PORTABLE |
| Applicant | Creative Biomedics, Inc. |
| Product Code | BZC · Anesthesiology |
| Decision Date | Aug 11, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.