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FDA Product Code

FDA Product Code DRI — Clearance Directory

Device Class
Class I
Assigned Panel
Cardiovascular
21 CFR Citation
870.2620

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K902492 CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S Datex Division Instrumentarium Corp. 1990-07-06 Traditional PDF ↗
K902493 CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR Datex Division Instrumentarium Corp. 1990-07-06 Traditional PDF ↗
K822316 HEART MONITOR BRACELET ALARM Hmba 1982-09-21 Traditional PDF ↗
K802326 PRESSURE MONITORING LINES Stanco Medical, Inc. 1980-10-10 Traditional PDF ↗

Product code DRI · Class I · Cardiovascular. Data: openFDA.