FDA 510(k) Application Details - K163109

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K163109
Device Name	Chamber, Hyperbaric
Applicant	OXYHEAL MEDICAL SYSTEMS, INC. 3224 HOOVER AVE NATIONAL CITY, CA 91950 US Other 510(k) Applications for this Company
Contact	EDWARD J. CHOMAS Other 510(k) Applications for this Contact
Regulation Number	868.5470   More FDA Info for this Regulation Number
Classification Product Code	CBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2016
Decision Date	03/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review