Device Classification Name |
calculator, predicted values, pulmonary function
|
510(k) Number |
K000648 |
Device Name |
SPIRO PRO |
Applicant |
ERICH JAEGER GMBH |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Applicant Contact |
LARRY MURDOCK |
Correspondent |
ERICH JAEGER GMBH |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Correspondent Contact |
LARRY MURDOCK |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 02/28/2000 |
Decision Date | 03/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|