Device Classification Name |
Spirometer, Monitoring (W/Wo Alarm)
|
510(k) Number |
K921717 |
Device Name |
BICORE SMARTVALVE OCCLUSION VALVE |
Applicant |
BICORE MONITORING SYSTEMS |
2 FARADAY |
IRVINE,
CA
92718
|
|
Applicant Contact |
MUIR S MEINHOLD |
Correspondent |
BICORE MONITORING SYSTEMS |
2 FARADAY |
IRVINE,
CA
92718
|
|
Correspondent Contact |
MUIR S MEINHOLD |
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 04/09/1992 |
Decision Date | 11/06/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|