The following data is part of a premarket notification filed by Specialty Water Technologies with the FDA for Upt Series Medical Ro Water System.
Device ID | K151637 |
510k Number | K151637 |
Device Name: | UPT Series Medical RO Water System |
Classification | Subsystem, Water Purification |
Applicant | Specialty Water Technologies 1020 Industrial Drive Orlinda, TN 37141 |
Contact | Alex Clark |
Correspondent | Alex Clark Specialty Water Technologies 1020 Industrial Drive Orlinda, TN 37141 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-17 |
Decision Date | 2015-09-23 |
Summary: | summary |