510(k) K200670

EON Portable RO Water Purification System by Mar Cor Purification, Inc. — Product Code FIP

K200670 is an FDA 510(k) premarket notification submitted by Mar Cor Purification, Inc. for the device "EON Portable RO Water Purification System". The FDA issued a decision of Substantially Equivalent on April 16, 2020. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Mar Cor Purification, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2020
Date Received
March 13, 2020
Clearance Type
Special
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