NEONATAL BREATHING CIRCUIT MODIFICATION
Device Facts
| Record ID | K932288 |
|---|---|
| Device Name | NEONATAL BREATHING CIRCUIT MODIFICATION |
| Applicant | Simplex Medical Systems, Inc. |
| Product Code | CAI · Anesthesiology |
| Decision Date | Dec 30, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5240 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.