Ethox Relia-Flo 2001 Enteral Feed
FDA 510(k) K841512 · Ethox Corp.
510(k) numberK841512
Submission
- Device name
- Ethox Relia-Flo 2001 Enteral Feed
- Applicant
- Ethox Corp.
Mchenry, IL, US - Received
- April 12, 1984
- Decision date
- May 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K894927 | Surgi SqueezKZD · Traditional | 09/11/1989SE |
| K883977 | Surgi-Cuf Sterile/Non-Sterile DisposableDXQ · Traditional | 02/10/1989SE |
| K860599 | Ethox Lavage TubeKDH · Traditional | 03/11/1986SE |
| K844988 | Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos.DXQ · Traditional | 04/04/1985SE |
Questions and answers
When was Ethox Relia-Flo 2001 Enteral Feed cleared by the FDA?
Ethox Relia-Flo 2001 Enteral Feed (K841512) received a 510(k) decision of Substantially Equivalent on May 21, 1984, 39 days after the submission was received.
What is the product code of K841512?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.