Enteral Nutrition Warmer
FDA 510(k) K122449 · Acacia, Inc.
510(k) numberK122449
Submission
- Device name
- Enteral Nutrition Warmer
- Applicant
- Acacia, Inc.
Brea, CA, US - Received
- August 13, 2012
- Decision date
- June 13, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K972538 | Flow-Eze Blunt Cannula (1999BC)FMI · Traditional | 07/15/1998SE |
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| K912771 | Acacias Pharm/PumpLHI · Traditional | 02/14/1992SE |
| K901063 | Luer Lock Transfer PinLHI · Traditional | 07/06/1990SE |
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| K894206 | IntopoFMF · Traditional | 10/27/1989SE |
Questions and answers
When was Enteral Nutrition Warmer cleared by the FDA?
Enteral Nutrition Warmer (K122449) received a 510(k) decision of Substantially Equivalent on June 13, 2013, 304 days after the submission was received.
What is the product code of K122449?
The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.