510(k) K101552

FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 by Foshan Care Medical Technology Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2011
Date Received
June 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type