Device Classification Name |
Calculator, Pulmonary Function Data
|
510(k) Number |
K900696 |
Device Name |
BIORE CP-100 CARDIOPULMONARY MONITOR |
Applicant |
BICORE MONITORING SYSTEMS |
2 FARADAY |
IRVINE,
CA
92718
|
|
Applicant Contact |
DAVID B VIELE |
Correspondent |
BICORE MONITORING SYSTEMS |
2 FARADAY |
IRVINE,
CA
92718
|
|
Correspondent Contact |
DAVID B VIELE |
Regulation Number | 868.1880
|
Classification Product Code |
|
Date Received | 02/13/1990 |
Decision Date | 11/29/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|