510(k) K951739
K951739 is an FDA 510(k) premarket notification submitted by Via Medical Corp. for the device "PUMP/BLOOD CHEMISTRY MONITOR". The FDA issued a decision of Substantially Equivalent on February 28, 1996. The device falls under product code LZF (Pump, Infusion, Analytical Sampling), a Class II device regulated under 21 CFR 880.5725. Via Medical Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1996
- Date Received
- April 14, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Analytical Sampling
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- CH
- Submission Type