510(k) K802166

MODEL AS* 7B AUTOSYRINGE INFUSION PUMP by Baxter Healthcare Corp — Product Code FLN

K802166 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MODEL AS* 7B AUTOSYRINGE INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on Nov 12, 1980. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 12, 1980
Date Received
Sep 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Device Class
Class II
Regulation Number
880.2420
Review Panel
HO
Submission Type
510(k)

Source: FDA 510(k) database entry for K802166. Report a data issue: hello@regdatalab.com.