FDA.report

510(k) K070125

Device
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K070125
Product code
FRN  
Decision
Substantially Equivalent (SESE)
Decision date
2007-04-16
Date received
2007-01-16
Regulation
880.5725
Classification name
Pump, Infusion
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JEME WALLACE
Address
1620 Waukegan Rd. Mcgaw Park IL US 60085 60085

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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