Perfusor Space Infusion Syringe Pump System
FDA 510(k) K062699 · B.Braun Medical, Inc.
510(k) numberK062699
Submission
- Device name
- Perfusor Space Infusion Syringe Pump System
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- September 11, 2006
- Decision date
- October 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Infusion Syringe Pump System cleared by the FDA?
Perfusor Space Infusion Syringe Pump System (K062699) received a 510(k) decision of Substantially Equivalent on October 26, 2006, 45 days after the submission was received.
What is the product code of K062699?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.