Vasomedical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K111180VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL June 28, 2011
K111096VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDIJune 24, 2011
K092785COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301April 2, 2010
K083820VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-CApril 1, 2009
K033617EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRYMarch 1, 2004
K020857EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EJune 14, 2002
K003469EECP THERAPY SYSTEM, MODEL TS3December 6, 2000