SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
Device Facts
| Record ID | K892121 |
|---|---|
| Device Name | SPIRO-LINK REAL TIME SPIROMETRY SYSTEM |
| Applicant | Biocom Intl., Inc. |
| Product Code | BZC · Anesthesiology |
| Decision Date | Jun 16, 1989 |
| 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.