Perfusor® Space Syringe Infusion Pump System
FDA 510(k) K172831 · B.Braun Medical, Inc.
510(k) numberK172831
Submission
- Device name
- Perfusor® Space Syringe Infusion Pump System
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- September 18, 2017
- Decision date
- June 12, 2018
- 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 Perfusor® Space Syringe Infusion Pump System cleared by the FDA?
Perfusor® Space Syringe Infusion Pump System (K172831) received a 510(k) decision of Substantially Equivalent on June 12, 2018, 267 days after the submission was received.
What is the product code of K172831?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.