| Device Classification Name |
ventilator, emergency, manual (resuscitator) |
|||
|---|---|---|---|---|
| 510(k) Number | K021446 | |||
| Device Name | OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR | |||
| Original Applicant |
|
|||
| Original Contact | kevin walls | |||
| Regulation Number | 868.5915 | |||
| Classification Product Code |
|
|||
| Date Received | 05/06/2002 | |||
| Decision Date | 10/11/2002 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Anesthesiology |
|||
| 510k Review Panel |
Anesthesiology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |