Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K910040 |
Device Name |
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT |
Applicant |
AMBU, INC. |
7476 NEW RIDGE RD-STE D |
HANOVER,
MD
21076
|
|
Applicant Contact |
DAVID LEE |
Correspondent |
AMBU, INC. |
7476 NEW RIDGE RD-STE D |
HANOVER,
MD
21076
|
|
Correspondent Contact |
DAVID LEE |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 01/04/1991 |
Decision Date | 05/28/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|