The following data is part of a premarket notification filed by Nelson Environmental Technologies, Inc. with the FDA for Nelson Sentinel Series Basic Chlorine Sentinel.
Device ID | K193169 |
510k Number | K193169 |
Device Name: | Nelson Sentinel Series Basic Chlorine Sentinel |
Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
Applicant | Nelson Environmental Technologies, Inc. 813 E. Fir Avenue Mcallen, TX 78501 |
Contact | Quochuy (huy) Nquyen |
Correspondent | Quochuy (huy) Nquyen Nelson Environmental Technologies, Inc. 813 E. Fir Avenue Mcallen, TX 78501 |
Product Code | MSY |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-15 |
Decision Date | 2020-10-29 |