DXM · Class II · 21 CFR 870.1450

FDA Product Code DXM: Densitometer

Leading manufacturers include Waters Assoc., Inc. and Instromedix, Inc..

2
Total
2
Cleared
49d
Avg days
1978
Since

FDA 510(k) Cleared Densitometer Devices (Product Code DXM)

2 devices
1–2 of 2
Cleared Nov 05, 1979
TAPE-A-TRACE
K791892
Instromedix, Inc.
Cardiovascular · 41d
Cleared Nov 29, 1978
CALIBRATOR, DYNAMIC
K781692
Waters Assoc., Inc.
Cardiovascular · 56d

About Product Code DXM - Regulatory Context