Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K873043 |
Device Name |
MOUTH TO FACE RESUSCITATOR |
Applicant |
ARTEC ENVIRONMENTAL MONITORING DIVISION |
P.O. BOX 68 |
NOBLESVILLE,
IN
46060
|
|
Applicant Contact |
TIMOTHY D STRUTHERS |
Correspondent |
ARTEC ENVIRONMENTAL MONITORING DIVISION |
P.O. BOX 68 |
NOBLESVILLE,
IN
46060
|
|
Correspondent Contact |
TIMOTHY D STRUTHERS |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 08/04/1987 |
Decision Date | 09/28/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|