Elekon Industries U.S.A., Inc. - FDA 510(k) Cleared Devices
Recent clearances: DISPOSABLE NON-ADHESIVE SPO2 SENSORS, FLEXI-STAT SP02 EAR SENSOR, REUSABLE FINGER CLIP SPO2 SENSORS
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elekon Industries U.S.A., Inc. Anesthesiology ✕
6 devices
Cleared
Dec 29, 2004
DISPOSABLE NON-ADHESIVE SPO2 SENSORS
Anesthesiology
90d
Cleared
Dec 06, 2004
FLEXI-STAT SP02 EAR SENSOR
Anesthesiology
68d
Cleared
Nov 26, 2004
REUSABLE FINGER CLIP SPO2 SENSORS
Anesthesiology
57d
Cleared
Sep 14, 2004
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
Anesthesiology
99d
Cleared
Sep 02, 2004
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS...
Anesthesiology
77d
Cleared
Jul 29, 2004
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE),...
Anesthesiology
42d