510(k) K944320
K944320 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "VENTED/NON-VENTED GEMINI ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on February 14, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Imed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1995
- Date Received
- August 29, 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