Circadiance

FDA Filings

This page includes the latest FDA filings for Circadiance. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3006182632
FEI Number	3006182632
Name	CIRCADIANCE
Owner & Operator	Circadiance
Contact Address	1300 Rodi Rd. Turtle Creek PA 15145 US
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	1300 Rodi Rd Turtle Creek, PA 15145 US
Establishment Type	Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K162905 \| BZD CIRCADIANCE	SleepWeaver 3D Nasal Mask	2017-03-22
PMN K151683 \| BZD CIRCADIANCE	SleepWeaver Advance Pediatric Nasal CPAP Mask	2016-06-23
PMN K103410 \| BZD CIRCADIANCE	NeoPAP System	2015-07-15
PMN K061256 \| NPF CIRCADIANCE	SmartMonitor 2 PS	2015-07-15
PMN K061256 \| DQA CIRCADIANCE	SmartMonitor 2 PS	2015-07-15
PMN K032403 \| NPF CIRCADIANCE	SmartMonitor 2 Professional Series	2015-07-15
PMN K032403 \| DQA CIRCADIANCE	SmartMonitor 2 Professional Series	2015-07-15
PMN K011597 \| FLS CIRCADIANCE	SmartMonitor 2 / Synergy-E	2015-07-15
PMN K130481 \| BZD CIRCADIANCE	SleepWeaver Anew Full Face Soft Cloth PAP Mask	2013-07-12
PMN K120757 \| BZD CIRCADIANCE	SleepWeaver Elan Nasal CPAP Mask	2012-12-19
PMN K092362 \| BZD CIRCADIANCE	SleepWeaver Nasal CPAP Mask	2009-12-07
BYG CIRCADIANCE	SleepWeaver FeatherWeight Tube	2008-12-29

Similar & Related FDA Registered Companies

Circadiance, LLC

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019071722397	Istanbul,Turkey -> New York/Newark Area, Newark, New Jersey	CPAP DEVICE AND ACCESSORIES(CANUL,BONE)	5 PCS
2019070633176	Istanbul,Turkey -> New York/Newark Area, Newark, New Jersey	CPAP DEVICE AND ACCESSORIES(CANUL,BONE)	5 PCS