Advanced Instrumentations, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemDecember 1, 2017
K172055DUS-7000 Digital Color Doppler Ultrasound SystemAugust 31, 2017
K141194FM-3000 FETAL MONITORNovember 19, 2014
K132077PATIENT MONITORApril 23, 2014
K132059DIAGNOSTIC ULTRASOUND SYSTEMOctober 25, 2013
K123048PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PROJanuary 11, 2013
K120075AM-6000 ANESTHESIA MACHINEJanuary 26, 2012
K112317FM-9000 PLUS FETAL AND MATERNAL MONITORDecember 21, 2011
K112529TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLEROctober 27, 2011
K111934PD-100 SERIES ULTRASONIC POCKET DOPPLERSeptember 22, 2011
K112022DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMSeptember 22, 2011
K112187FM-1000 PLUS FETAL MONITORSeptember 21, 2011
K112159CMS-1000FM CENTRAL MONITORING SYSTEMSeptember 21, 2011
K111805ECG SERIES ELECTROCARDIOGRAPHAugust 24, 2011
K112135ECG-6 SERIES ELECTROCARDIOGRAPHAugust 5, 2011
K082887PM-1000F+PATIENT MONITORJanuary 16, 2009