Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K912415 |
Device Name |
MEDICAL SAFETY CABLE AND LEAD SYSTEM |
Applicant |
MEDTRONIC VASCULAR |
60 NEWARK ST. |
HAVERHILL,
MA
01830
|
|
Applicant Contact |
JANICE M PEVIDE |
Correspondent |
MEDTRONIC VASCULAR |
60 NEWARK ST. |
HAVERHILL,
MA
01830
|
|
Correspondent Contact |
JANICE M PEVIDE |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 05/31/1991 |
Decision Date | 08/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|