Accuflow and Accuflux Elastomeric Infusion Pump
FDA 510(k) K081905 · Westmed, Inc.
510(k) numberK081905
Submission
- Device name
- Accuflow and Accuflux Elastomeric Infusion Pump
- Applicant
- Westmed, Inc.
Highlands Ranch, CO, US - Received
- July 3, 2008
- Decision date
- July 15, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- MEB – Pump, Infusion, Elastomeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Accuflow and Accuflux Elastomeric Infusion Pump cleared by the FDA?
Accuflow and Accuflux Elastomeric Infusion Pump (K081905) received a 510(k) decision of Substantially Equivalent on July 15, 2008, 12 days after the submission was received.
What is the product code of K081905?
The FDA product code is MEB – Pump, Infusion, Elastomeric, a Class II (moderate risk) device regulated under 21 CFR 880.5725.