The following data is part of a premarket notification filed by Darco Water Systems, Inc. with the FDA for Water Conductivity Monitor & Controller.
Device ID | K800305 |
510k Number | K800305 |
Device Name: | WATER CONDUCTIVITY MONITOR & CONTROLLER |
Classification | Subsystem, Water Purification |
Applicant | DARCO WATER SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-01 |
Decision Date | 1980-04-08 |