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FDA 510(k) Applications Submitted by HEARTLAB, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K050228
02/01/2005
AGFA HEARTLAB CARDIOVASCULAR
HEARTLAB, INC.
K050858
04/05/2005
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
HEARTLAB, INC.
K040896
04/06/2004
MODIFICATION TO ENCOMPASS
HEARTLAB, INC.
K042042
07/29/2004
ULTRASOUND CAPTURE SYSTEM
HEARTLAB, INC.
K954479
09/26/1995
DICOMVIEW
HEARTLAB, INC.
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