BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM

Subsystem, Water Purification

MAR COR PURIFICATION, INC.

The following data is part of a premarket notification filed by Mar Cor Purification, Inc. with the FDA for Biopure Hx2 Reverse Osmosis Water Purification System.

Pre-market Notification Details

• Device ID: K133149
• 510k Number: K133149
• Device Name: BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
• Classification: Subsystem, Water Purification
• Applicant: MAR COR PURIFICATION, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55447
• Contact: Kinnari Shah
• Correspondent: Kinnari Shah; MAR COR PURIFICATION, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55447
• Product Code: FIP
• CFR Regulation Number: 876.5665 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-17
• Decision Date: 2014-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817492021884	K133149	000
00817492021709	K133149	000
00817492021716	K133149	000
00817492021723	K133149	000
00817492021822	K133149	000
00817492021839	K133149	000
00817492021846	K133149	000
00817492021853	K133149	000
00817492021877	K133149	000
00817492021693	K133149	000