Electromed, Inc. is one of 16067 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Electromed, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Electromed SmartVest Airway Clearance System, SMARTVEST AIRWAY CLEARANCE SYSTEM, SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
5
Total
5
Cleared
0
Denied
Electromed, Inc. has 5 FDA 510(k) cleared medical devices. Based in New Prague, US.
Last cleared in 2022. Active since 1999. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Electromed, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Intertek Testing Services as regulatory consultant.
FDA 510(k) Regulatory Record - Electromed, Inc.
5 devices
Cleared
Nov 18, 2022
Electromed SmartVest Airway Clearance System
Anesthesiology
92d
Cleared
Dec 19, 2013
SMARTVEST AIRWAY CLEARANCE SYSTEM
Anesthesiology
104d
Cleared
Dec 01, 2005
SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
Anesthesiology
10d
Cleared
Apr 07, 2004
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
Anesthesiology
54d
Cleared
Jun 01, 1999
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
Anesthesiology
288d