Medical Device Manufacturer · US , Fort Myers , FL

Disetronic Medical Systems AG - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2000

Recent clearances: ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE, ACCU-CHEK ULTRAFLEX INFUSION SET, ACCU-CHEK LINKASSIST

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Disetronic Medical Systems AG General Hospital ✕

12 devices

1-12 of 12

Cleared May 14, 2010

ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION...

General Hospital · 63d

Cleared Feb 21, 2007

ACCU-CHEK ULTRAFLEX INFUSION SET

General Hospital · 30d

Cleared Nov 27, 2006

ACCU-CHEK LINKASSIST

General Hospital · 42d

Cleared Jun 15, 2006

ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001

General Hospital · 76d

Cleared Mar 18, 2005

ACCU-CHEK SPIRIT

General Hospital · 150d

Cleared Dec 01, 2004

MODIFICATION TO D-TRONPLUS

General Hospital · 30d

Cleared Mar 09, 2004

ULTRAFLEX INFUSION SET

General Hospital · 84d

Cleared Oct 29, 2002

DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP

General Hospital · 14d

Cleared Sep 11, 2002

MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP

General Hospital · 16d

Cleared Aug 02, 2002

DISETRONIC D-TRON INSULIN INFUSION PUMP

General Hospital · 70d

Cleared Feb 15, 2001

DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D...

General Hospital · 55d

Cleared Jun 21, 2000

DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM

General Hospital · 26d