ULTIMATE SEAL
Device Facts
| Record ID | K960401 |
|---|---|
| Device Name | ULTIMATE SEAL |
| Applicant | Hans Rudolph, Inc. |
| Product Code | KGB · Anesthesiology |
| Decision Date | Jun 20, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5570 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.
