Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K883434 |
Device Name |
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) |
Applicant |
AMBU, INC. |
7476 NEW RIDGE RD-STE D |
HANOVER,
MD
21076
|
|
Applicant Contact |
FRANK HOMA |
Correspondent |
AMBU, INC. |
7476 NEW RIDGE RD-STE D |
HANOVER,
MD
21076
|
|
Correspondent Contact |
FRANK HOMA |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 08/15/1988 |
Decision Date | 09/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|