SYNCHRONER TM (PROPOSED TRADENAME)
Device Facts
| Record ID | K853350 |
|---|---|
| Device Name | SYNCHRONER TM (PROPOSED TRADENAME) |
| Applicant | Fisons Corp. |
| Product Code | CCQ · Anesthesiology |
| Decision Date | Aug 29, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5640 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.