Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K924413 |
Device Name |
FLOWSCAN |
Applicant |
ELECTROCAINE MEDICAL SYSTEM |
STERLING CENTER, |
20-E EAST ROSEVILLE ROAD |
LANCASTER,
PA
17601
|
|
Applicant Contact |
STOOLE |
Correspondent |
ELECTROCAINE MEDICAL SYSTEM |
STERLING CENTER, |
20-E EAST ROSEVILLE ROAD |
LANCASTER,
PA
17601
|
|
Correspondent Contact |
STOOLE |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 08/31/1992 |
Decision Date | 05/06/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|