INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400
Device Facts
| Record ID | K011344 |
|---|---|
| Device Name | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 |
| Applicant | Collins Medical, Inc. |
| Product Code | BZC · Anesthesiology |
| Decision Date | May 17, 2002 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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.