Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K020280 |
Device Name |
PULMOLAB EX671 EXERCISE TESTING SYSTEM |
Applicant |
MORGAN MEDICAL LTD. |
555 THIRTEENTH ST. NW |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
MORGAN MEDICAL LTD. |
555 THIRTEENTH ST. NW |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 01/28/2002 |
Decision Date | 09/24/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|