FDA 510(k) Application Details - K193069

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K193069
Device Name	Sleeve, Limb, Compressible
Applicant	AIROS Medical, Inc. 2501 Monroe Blvd. Suite 1200 Audubon, PA 19403 US Other 510(k) Applications for this Company
Contact	Darren Behuniak Other 510(k) Applications for this Contact
Regulation Number	870.5800   More FDA Info for this Regulation Number
Classification Product Code	JOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2019
Decision Date	12/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review