510(k) K932408

AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS by Baxter Healthcare Corp — Product Code FFN

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 September 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 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