510(k) K932408
K932408 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS". The FDA issued a decision of Substantially Equivalent on Sep 28, 1993. The device falls under product code FFN (Clamp, Non-Electrical), a Class I device regulated under 21 CFR 876.4730. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 1993
- Date Received
- May 18, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Clamp, Non-Electrical
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type
- 510(k) Exempt