Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Edentec Corp.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K953363 OXIFLOW DIGITAL RECORDERBZQ1996-02-06 View
510(k) K953540 EEEBYD1995-08-25 View
510(k) K921819 EDENTEC MODEL 3710 I DIGITAL PRINTERBZQ1993-10-22 View
510(k) K913749 EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170BZQ1992-07-02 View
510(k) K910870 EDENTEC MODEL 3711 DIGITAL RECORDERDRT1991-08-29 View
510(k) K910871 EDENTEC DIGITAL CHARTER MODEL 3710DSF1991-08-29 View
510(k) K905575 MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MONBZQ1991-06-20 View
510(k) K901060 EDENTEC MODEL 2000W SYSTEM 700 MONITORDQA1990-05-15 View
510(k) K893561 EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.DSF1989-08-25 View
510(k) K892227 EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)DSH1989-06-20 View
510(k) K891540 EDENTEC MODEL 2860 PRESSURE METERBYE1989-06-01 View
510(k) K884614 EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.DQA1989-02-01 View
510(k) K884388 EDENTEC MODEL 4700 SCANNERDSF1989-01-10 View
510(k) K883315 EDENTRACE MULTI-CHARTER MODEL 3700DSF1988-12-28 View
510(k) K881820 EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETERDQA1988-07-18 View
510(k) K873081 EDENTEC MULTI-CHANNEL RECORDERDQA1987-11-17 View
510(k) K871302 MODEL 2000W OPTION H CONFIGURATIONBZQ1987-04-20 View
510(k) K844327 EDENTEC MODEL 2000W APNEA MONITORBZQ1985-07-15 View
↑