510(k) K021274

PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 by Baxter Healthcare Corp — Product Code MEB

K021274 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719". The FDA issued a decision of Substantially Equivalent on May 17, 2002. 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
May 17, 2002
Date Received
Apr 22, 2002
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)

Source: FDA 510(k) database entry for K021274. Report a data issue: hello@regdatalab.com.