The following data is part of a premarket notification filed by Cooper-hewitt Electric Co. with the FDA for Aquanomics, #mp4sf.
Device ID | K813050 |
510k Number | K813050 |
Device Name: | AQUANOMICS, #MP4SF |
Classification | Purifier, Water, Ultraviolet, Medical |
Applicant | COOPER-HEWITT ELECTRIC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KMG |
CFR Regulation Number | 880.6710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-28 |
Decision Date | 1981-12-02 |