Device Classification Name |
oximeter
|
510(k) Number |
K041522 |
Device Name |
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS |
Applicant |
ELEKON INDUSTRIES U.S.A., INC. |
2300 MCDERMOTT RD. |
#200-207 |
PLANO,
TX
75025
|
|
Applicant Contact |
KRISTA OAKES |
Correspondent |
ELEKON INDUSTRIES U.S.A., INC. |
2300 MCDERMOTT RD. |
#200-207 |
PLANO,
TX
75025
|
|
Correspondent Contact |
KRISTA OAKES |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 06/07/2004 |
Decision Date | 09/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|