510(k) K983294

ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 by Baxter Healthcare Corp — Product Code KPE

K983294 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712". The FDA issued a decision of Substantially Equivalent on Nov 3, 1998. 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
Nov 3, 1998
Date Received
Sep 21, 1998
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)

Source: FDA 510(k) database entry for K983294. Report a data issue: hello@regdatalab.com.