Mergenet Medical receives 510(K)

The United States Food and Drug Administration has given us 510(K) clearance on the Trach-Assist device.

Below is from the FDA website:

 

Device Classification Name	connector, airway (extension)
510(k) Number	K083702
Device Name	TRACH-ASSIST
Applicant	MERGENET MEDICAL 24301 woodsage drive bonita springs,  FL  34134 295
Contact	paul dryden
Regulation Number	868.5810
Classification Product Code	BZA
Date Received	12/15/2008
Decision Date	03/05/2009
Decision	substantially equivalent (SE)
Classification Advisory Committee	Anesthesiology
Review Advisory Committee	Anesthesiology
Statement/Summary/Purged Status	Summary only
summary	summary
Type	Traditional
Reviewed by Third Party	No
Expedited Review	No