DXW · Class II · 21 CFR 870.1270

FDA Product Code DXW: System, Phonocatheter, Intracavitary

Leading manufacturers include Millar Instruments, Inc., Newmed Corp. and Cas Medical Systems, Inc..

5
Total
5
Cleared
131d
Avg days
1980
Since

FDA 510(k) Cleared System, Phonocatheter, Intracavitary Devices (Product Code DXW)

5 devices
1–5 of 5
Cleared May 05, 1998
OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
K972020
Cas Medical Systems, Inc.
Cardiovascular · 337d
Cleared Sep 05, 1996
NEWMED ABP-LITE
K955887
Newmed Corp.
Cardiovascular · 252d
Cleared Dec 10, 1980
MILLAR MIKRO-TIP CATHETER PHONOTRANS
K802830
Millar Instruments, Inc.
Cardiovascular · 30d

About Product Code DXW - Regulatory Context