FDA 510(k) Application Details - K012392

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K012392
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	PACE MEDICAL 391 TOTTEN POND RD. WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	ROBERT C MACE Other 510(k) Applications for this Contact
Regulation Number	870.2900   More FDA Info for this Regulation Number
Classification Product Code	DSA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2001
Decision Date	09/04/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review