510(k) K945193
K945193 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ALL-IN-ONE TWO CHAMBER CONTAINER". The FDA issued a decision of Substantially Equivalent on May 12, 1995. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1995
- Date Received
- Oct 24, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type
- 510(k)