Edan Instruments, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Holter ECG and ABP system (HolterABP), Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP), Fetal & Maternal Monitor (F15A, F15A Air)
92
Total
92
Cleared
0
Denied
FDA 510(k) Regulatory Record - Edan Instruments, Inc. Anesthesiology ✕
5 devices
Cleared
Aug 30, 2013
VITAL SIGNS MONITOR
Anesthesiology
71d
Cleared
Dec 27, 2010
VITAL SIGNS MONITOR
Anesthesiology
89d
Cleared
Nov 24, 2010
VITAL SIGNS MONITOR MODEL M3B
Anesthesiology
174d
Cleared
Dec 03, 2009
H100B PULSE OXIMETER
Anesthesiology
90d
Cleared
May 14, 2009
VITAL SIGNS MONITOR
Anesthesiology
143d