FDA 510(k) Application Details - K013027

Device Classification Name	Compressor, Air, Portable   More FDA Info for this Device
510(K) Number	K013027
Device Name	Compressor, Air, Portable
Applicant	RESPIRONICS HEALTHSCAN, INC. 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK Other 510(k) Applications for this Contact
Regulation Number	868.6250   More FDA Info for this Regulation Number
Classification Product Code	BTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2001
Decision Date	12/06/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review