Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K981445 |
Device Name |
ULTIMA AIRFLOW SENSOR, 0510 |
Applicant |
BRAEBON MEDICAL CORP. |
63 ACKLAM TERRACE |
KANATA,
CA
K2K 2H7
|
|
Applicant Contact |
RICHARD A BONATO |
Correspondent |
BRAEBON MEDICAL CORP. |
63 ACKLAM TERRACE |
KANATA,
CA
K2K 2H7
|
|
Correspondent Contact |
RICHARD A BONATO |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 04/22/1998 |
Decision Date | 10/05/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|