Dispenser DP 20
FDA 510(k) K071588 · Nouvag AG
510(k) numberK071588
Submission
- Device name
- Dispenser DP 20
- Applicant
- Nouvag AG
Gebenstorf, CH - Received
- June 11, 2007
- Decision date
- November 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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Questions and answers
When was Dispenser DP 20 cleared by the FDA?
Dispenser DP 20 (K071588) received a 510(k) decision of Substantially Equivalent on November 26, 2007, 168 days after the submission was received.
What is the product code of K071588?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.