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DXM – Densitometer
Densitometer
FDA product code
DXM
· Class II (moderate risk) · 21 CFR 870.1450 ·
Cardiovascular
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Waters Assoc., Inc.
1
Instromedix, Inc.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K791892
Tape-A-Trace
DXM · Traditional
Instromedix, Inc.
11/05/1979
SE
K781692
Calibrator, Dynamic
DXM · Traditional
Waters Assoc., Inc.
11/29/1978
SE