The following data is part of a premarket notification filed by Cantel with the FDA for Eon Portable Reverse Osmosis Water Purification System.
Device ID | K171099 |
510k Number | K171099 |
Device Name: | EON Portable Reverse Osmosis Water Purification System |
Classification | Subsystem, Water Purification |
Applicant | Cantel 14550 28th Avenue North Minneapolis, MN 55447 |
Contact | Mike Halliday |
Correspondent | Katlin Adamski Cantel 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 | 2017-04-13 |
Decision Date | 2018-01-05 |
Summary: | summary |