Purifier, Water (absorption, Deionization, Membrane Filter, Reverse Osmosis)

Device Code: 584

Product Code(s): JRS

Device Classification Information

• Device Type ID: 584
• Device Name: Purifier, Water (absorption, Deionization, Membrane Filter, Reverse Osmosis)
• Regulation Description: General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.2050 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JRS
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 584
• Device: Purifier, Water (absorption, Deionization, Membrane Filter, Reverse Osmosis)
• Product Code: JRS
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
• CFR Regulation Number: 862.2050 [🔎]

TPLC Last Update: 2019-04-02 19:36:53