Product code DRI— Cardiovascular

FDA has cleared 4 devices under product code DRI between 1980 and 1990, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19902 clearances
• 19821 clearance
• 19801 clearance

• Datex Division Instrumentarium Corp.2 clearances
• Stanco Medical, Inc.1 clearance
• Hmba1 clearance

• K902492 — CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2SDatex Division Instrumentarium Corp.·1990-07-06
• K902493 — CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITORDatex Division Instrumentarium Corp.·1990-07-06
• K822316 — HEART MONITOR BRACELET ALARMHmba·1982-09-21
• K802326 — PRESSURE MONITORING LINESStanco Medical, Inc.·1980-10-10