510(k) K944619
K944619 is an FDA 510(k) premarket notification submitted by Advanced Bioresearch Assoc. for the device "I.V.I.D. FLUID ADMINISTRATION SET MARKER". The FDA issued a decision of Substantially Equivalent on January 26, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Advanced Bioresearch Assoc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1995
- Date Received
- September 20, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type