510(k) K131622

MROZ REVERSE OSMOSIS SYSTEM by Ameriwater — Product Code FIP

K131622 is an FDA 510(k) premarket notification submitted by Ameriwater for the device "MROZ REVERSE OSMOSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on September 20, 2013. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Ameriwater has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2013
Date Received
June 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type