Device Classification Name |
Oximeter
|
510(k) Number |
K934091 |
Device Name |
OXISAT |
Applicant |
MARQUETTE ELECTRONICS, INC. |
100 MARQUETTE DR. |
JUPITER,
FL
33468
|
|
Applicant Contact |
MICHAEL T LAUGHRAN |
Correspondent |
MARQUETTE ELECTRONICS, INC. |
100 MARQUETTE DR. |
JUPITER,
FL
33468
|
|
Correspondent Contact |
MICHAEL T LAUGHRAN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/23/1993 |
Decision Date | 03/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|