Medical Device Manufacturer · US , Eden Prairie , MN

Edentec Corp. - FDA 510(k) Cleared Devices

18 submissions · 17 cleared · Since 1985
18
Total
17
Cleared
0
Denied

Edentec Corp. has 17 FDA 510(k) cleared medical devices. Based in Eden Prairie, US.

Historical record: 17 cleared submissions from 1985 to 1996. Primary specialty: Anesthesiology.

Browse the FDA 510(k) cleared devices submitted by Edentec Corp. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Edentec Corp.
18 devices
1-18 of 18
Cleared Feb 06, 1996
OXIFLOW DIGITAL RECORDER
K953363 · BZQ
Anesthesiology · 204d
Cleared Aug 25, 1995
EEE
K953540 · BYD
Anesthesiology · 28d
Cleared Oct 22, 1993
EDENTEC MODEL 3710 I DIGITAL PRINTER
K921819 · BZQ
Anesthesiology · 555d
Cleared Jul 02, 1992
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
K913749 · BZQ
Anesthesiology · 316d
Cleared Aug 29, 1991
EDENTEC MODEL 3711 DIGITAL RECORDER
K910870 · DRT
Cardiovascular · 181d
Cleared Aug 29, 1991
EDENTEC DIGITAL CHARTER MODEL 3710
K910871 · DSF
Cardiovascular · 181d
Cleared Jun 20, 1991
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575 · BZQ
Anesthesiology · 190d
Cleared May 15, 1990
EDENTEC MODEL 2000W SYSTEM 700 MONITOR
K901060 · DQA
Anesthesiology · 70d
Cleared Aug 25, 1989
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
K893561 · DSF
Cardiovascular · 108d
Cleared Jun 20, 1989
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
K892227 · DSH
Cardiovascular · 77d
Cleared Jun 01, 1989
EDENTEC MODEL 2860 PRESSURE METER
K891540 · BYE
Anesthesiology · 76d
Cleared Feb 01, 1989
EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.
K884614 · DQA
Anesthesiology · 89d
Cleared Jan 10, 1989
EDENTEC MODEL 4700 SCANNER
K884388 · DSF
Cardiovascular · 84d
Cleared Dec 28, 1988
EDENTRACE MULTI-CHARTER MODEL 3700
K883315 · DSF
Cardiovascular · 145d
Cleared Jul 18, 1988
EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER
K881820 · DQA
Anesthesiology · 80d
Cleared Nov 17, 1987
EDENTEC MULTI-CHANNEL RECORDER
K873081 · DQA
Anesthesiology · 104d
Cleared Apr 20, 1987
MODEL 2000W OPTION H CONFIGURATION
K871302 · BZQ
Anesthesiology · 19d
Cleared Jul 15, 1985
EDENTEC MODEL 2000W APNEA MONITOR
K844327 · BZQ
Anesthesiology · 250d
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