510(k) K971168
K971168 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE". The FDA issued a decision of Substantially Equivalent on Jul 15, 1997. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 15, 1997
- Date Received
- Mar 31, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pump, Infusion, Elastomeric
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
- 510(k)