Device Classification Name |
oximeter
|
510(k) Number |
K010413 |
Device Name |
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI |
Applicant |
KONICA MINOLTA SENSING, INC. |
458 S. RANDOM RD. |
BAILEY,
CO
80421
|
|
Applicant Contact |
NANCI DEXTER |
Correspondent |
KONICA MINOLTA SENSING, INC. |
458 S. RANDOM RD. |
BAILEY,
CO
80421
|
|
Correspondent Contact |
NANCI DEXTER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 02/12/2001 |
Decision Date | 08/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|