Edentec Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K953363OXIFLOW DIGITAL RECORDERFebruary 6, 1996
K953540EEEAugust 25, 1995
K921819EDENTEC MODEL 3710 I DIGITAL PRINTEROctober 22, 1993
K913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170July 2, 1992
K910870EDENTEC MODEL 3711 DIGITAL RECORDERAugust 29, 1991
K910871EDENTEC DIGITAL CHARTER MODEL 3710August 29, 1991
K905575MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MONJune 20, 1991
K901060EDENTEC MODEL 2000W SYSTEM 700 MONITORMay 15, 1990
K893561EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.August 25, 1989
K892227EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)June 20, 1989
K891540EDENTEC MODEL 2860 PRESSURE METERJune 1, 1989
K884614EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.February 1, 1989
K884388EDENTEC MODEL 4700 SCANNERJanuary 10, 1989
K883315EDENTRACE MULTI-CHARTER MODEL 3700December 28, 1988
K881820EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETERJuly 18, 1988
K873081EDENTEC MULTI-CHANNEL RECORDERNovember 17, 1987
K871302MODEL 2000W OPTION H CONFIGURATIONApril 20, 1987
K844327EDENTEC MODEL 2000W APNEA MONITORJuly 15, 1985