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 |