The following data is part of a premarket notification filed by Mar Cor Purification, Inc. with the FDA for Eon Portable Ro Water Purification System.
| Device ID | K200670 |
| 510k Number | K200670 |
| Device Name: | EON Portable RO Water Purification System |
| Classification | Subsystem, Water Purification |
| Applicant | Mar Cor Purification, Inc. 14550 28th Avenue North Minneapolis, MN 55447 |
| Contact | Mark Arnold |
| Correspondent | Mark Arnold Mar Cor Purification, Inc. 14550 28th Avenue North Minneapolis, MN 55447 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-13 |
| Decision Date | 2020-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817492022546 | K200670 | 000 |
| 00817492023710 | K200670 | 000 |