Microbar Monitoring Line Filter
FDA 510(k) K792510 · Medex, Inc.
510(k) numberK792510
Submission
- Device name
- Microbar Monitoring Line Filter
- Applicant
- Medex, Inc.
Mchenry, IL, US - Received
- December 5, 1979
- Decision date
- December 20, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPB – Filter, Infusion Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Microbar Monitoring Line Filter cleared by the FDA?
Microbar Monitoring Line Filter (K792510) received a 510(k) decision of Substantially Equivalent on December 20, 1979, 15 days after the submission was received.
What is the product code of K792510?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.