Paceart, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012407PACEART TX3 CARDIAC EVENT RECORDERAugust 14, 2001
K982090PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEMJanuary 26, 1999
K973141HEART ACCESS PLUS CARDIAC EVENT RECORDERNovember 12, 1997
K960721PACEART WRIST ELECTRODESJuly 18, 1996
K952065PACEART CARDIOVOICEJanuary 16, 1996
K931296PACEART CARDIOPHONEOctober 1, 1993
K915632PACEART CPTS-86/12April 14, 1992
K880283PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTSMarch 9, 1988
K870909PACEMAKER FUNCTION ANALYZERApril 27, 1987