Circadiance, LLC is one of 18347 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Circadiance, LLC - FDA 510(k) Cleared Devices
Recent clearances: SleepWeaver 3D Nasal Mask, SleepWeaver Advance Pediatric Nasal CPAP Mask, SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
5
Total
5
Cleared
0
Denied
Circadiance, LLC has 5 FDA 510(k) cleared medical devices. Based in Murrysville, US.
Historical record: 5 cleared submissions from 2009 to 2017. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Circadiance, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory & Quality Solutions, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Circadiance, LLC
5 devices
Cleared
Mar 15, 2017
SleepWeaver 3D Nasal Mask
Anesthesiology
149d
Cleared
Apr 05, 2016
SleepWeaver Advance Pediatric Nasal CPAP Mask
Anesthesiology
288d
Cleared
May 24, 2013
SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
Anesthesiology
88d
Cleared
Apr 24, 2012
SLEEPWEAVER ELAN NASAL CPAP MASK
Anesthesiology
42d
Cleared
Nov 02, 2009
SLEEPWEAVER NASAL CPAP MASK
Anesthesiology
90d