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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K901612
Device Name VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE
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 Number870.2700
Classification Product Code
DQA  
Date Received04/06/1990
Decision Date 04/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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