Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K971336 |
Device Name |
CAIRD TECHNOLOGY SPIROMETER |
Applicant |
CAIRD TECHNOLOGY |
205 CAMDEN CHASE |
COLUMBIA,
SC
29223
|
|
Applicant Contact |
JAMES H BROWN |
Correspondent |
CAIRD TECHNOLOGY |
205 CAMDEN CHASE |
COLUMBIA,
SC
29223
|
|
Correspondent Contact |
JAMES H BROWN |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 04/10/1997 |
Decision Date | 12/01/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|