Device Classification Name |
valve, non-rebreathing
|
510(k) Number |
K001742 |
Device Name |
RESUSCI INFLATE-A-SHIELD CPR BARRIER |
Applicant |
LAERDAL MEDICAL CORP. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
CYNTHIA J NOLTE |
Correspondent |
LAERDAL MEDICAL CORP. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
CYNTHIA J NOLTE |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 06/08/2000 |
Decision Date | 10/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|