DRI · Class I · 21 CFR 870.2620

FDA Product Code DRI: Monitor, Line Isolation

Leading manufacturers include Datex Division Instrumentarium Corp. and Stanco Medical, Inc..

4
Total
4
Cleared
32d
Avg days
1980
Since

FDA 510(k) Cleared Monitor, Line Isolation Devices (Product Code DRI)

4 devices
1–4 of 4
Cleared Jul 06, 1990
CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S
K902492
Datex Division Instrumentarium Corp.
Cardiovascular · 31d
Cleared Jul 06, 1990
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
K902493
Datex Division Instrumentarium Corp.
Cardiovascular · 31d
Cleared Oct 10, 1980
PRESSURE MONITORING LINES
K802326
Stanco Medical, Inc.
Cardiovascular · 17d

About Product Code DRI - Regulatory Context