The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Ethox Relia-flo 2001 Enteral Feed.
Device ID | K841512 |
510k Number | K841512 |
Device Name: | ETHOX RELIA-FLO 2001 ENTERAL FEED |
Classification | Pump, Infusion |
Applicant | ETHOX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-12 |
Decision Date | 1984-05-21 |