FDA 510(k) Application Details - DEN170072

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170072
Device Name	Enlight 1810
Applicant	Timpel Inc. R. Simao Alvares 356 cj.41-Pinheiros Sao Paulo-SP 05417-020 BR Other 510(k) Applications for this Company
Contact	Rafael Holzhacker Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	12/20/2018
Decision	DENG -
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review