The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Ethox/barron #2000 Food Pump-enteral Fed.
Device ID | K803190 |
510k Number | K803190 |
Device Name: | ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED |
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 | 1980-12-16 |
Decision Date | 1981-01-09 |