MP-4400 MOUTHPIECE-FLANGE SEAL
Device Facts
| Record ID | K862788 |
|---|---|
| Device Name | MP-4400 MOUTHPIECE-FLANGE SEAL |
| Applicant | Medipart Jerry Alexander |
| Product Code | BYP · Anesthesiology |
| Decision Date | Aug 1, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5620 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.