Company ยท US
Edentec Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1996. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 1996 | K953363 | OXIFLOW DIGITAL RECORDER Edentec Corp. | BZQ |
| Aug 25, 1995 | K953540 | EEE Edentec Corp. | BYD |
| Oct 22, 1993 | K921819 | EDENTEC MODEL 3710 I DIGITAL PRINTER Edentec Corp. | BZQ |
| Jul 2, 1992 | K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 Edentec Corp. | BZQ |
| Aug 29, 1991 | K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 Edentec Corp. | DSF |
| Aug 29, 1991 | K910870 | EDENTEC MODEL 3711 DIGITAL RECORDER Edentec Corp. | DRT |
| Jun 20, 1991 | K905575 | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON Edentec Corp. | BZQ |
| May 15, 1990 | K901060 | EDENTEC MODEL 2000W SYSTEM 700 MONITOR Edentec Corp. | DQA |
| Aug 25, 1989 | K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. Edentec Corp. | DSF |
| Jun 20, 1989 | K892227 | EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) Edentec Corp. | DSH |
| Jun 1, 1989 | K891540 | EDENTEC MODEL 2860 PRESSURE METER Edentec Corp. | BYE |
| Feb 1, 1989 | K884614 | EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. Edentec Corp. | DQA |
| Jan 10, 1989 | K884388 | EDENTEC MODEL 4700 SCANNER Edentec Corp. | DSF |
| Dec 28, 1988 | K883315 | EDENTRACE MULTI-CHARTER MODEL 3700 Edentec Corp. | DSF |
| Jul 18, 1988 | K881820 | EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER Edentec Corp. | DQA |
| Nov 17, 1987 | K873081 | EDENTEC MULTI-CHANNEL RECORDER Edentec Corp. | DQA |
| Apr 20, 1987 | K871302 | MODEL 2000W OPTION H CONFIGURATION Edentec Corp. | BZQ |
| Jul 15, 1985 | K844327 | EDENTEC MODEL 2000W APNEA MONITOR Edentec Corp. | BZQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||