510(k) K243392
- Device
- Infusomat® Space Volumetric Infusion Pump Administration Sets
- Applicant
- B.Braun Medical, Inc.
- 510(k) number
- K243392
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-24
- Date received
- 2024-10-31
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Rushtin Chaklader
- Address
- 3773 Corporate Pkwy. Center Valley PA US 18034 18034
FDA Registration Numbers
- 1450662
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Source Documents
Other 510(k) Records For Product Code FPA
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|---|---|---|---|
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