Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K001743 |
Device Name |
ULTIMA SMARTBELT, MODEL 0560 |
Applicant |
BRAEBON MEDICAL CORP. |
120 WALGREEN DR (RR#3) |
SUITE #1 |
CARP, ONTARIO,
CA
K0A 1L0
|
|
Applicant Contact |
RICHARD A BONATO |
Correspondent |
BRAEBON MEDICAL CORP. |
120 WALGREEN DR (RR#3) |
SUITE #1 |
CARP, ONTARIO,
CA
K0A 1L0
|
|
Correspondent Contact |
RICHARD A BONATO |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 06/08/2000 |
Decision Date | 08/25/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|