Device Classification Name |
Oximeter
|
510(k) Number |
K901066 |
Device Name |
VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA. |
Applicant |
PACE TECH, INC. |
1060 CEPHAS RD. |
CLEARWATER,
FL
34625
|
|
Applicant Contact |
MARY J BILGUTAY |
Correspondent |
PACE TECH, INC. |
1060 CEPHAS RD. |
CLEARWATER,
FL
34625
|
|
Correspondent Contact |
MARY J BILGUTAY |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/07/1990 |
Decision Date | 08/28/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|