510(k) K251640

Device: SIGMA Spectrum Infusion Pump with Master Drug Library
Applicant: Baxter Healthcare Corporation
510(k) number: K251640
Product code: FRN
Decision: Substantially Equivalent (SESE)
Decision date: 2025-07-28
Date received: 2025-05-29
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: N

Related Records

Applicant Contact

Contact: Jessica Andreshak
Address: One Baxter Pkwy. Deerfield Lake IL US 60015 60015

FDA Registration Numbers

9617594
1423537
2024022
3004906872
2029275
3009754410
3006575795
1526611
2528981
3003098013
1222313
2523167
2244478
3005700264
2024064
3004986960
3008058400
2520313
3015158050
9680787
3005778453
1066270
3015276780
9710049
9617604
3020777588
2027804
3042027705
1047843
2032112
3018094310
2011171
9680741
3003879246
3012302888
1319639
3002879653
1928237
1423507
1018470
3013652261
9680425
3017636737
3003144120
2022994
1721686
3010564249
9610847
9615908
9610825
1220477
2032862
9615050
2219920
2029015
9710593
3010273872
1921846
3004112621
3018229072
1123137
3013764800
3024706751
3024122953
3005627859
9617787
3000240707
9612051
1643817
3015972753
2032227
3008513006
3004530184
1045254
9612030
1061124
3010293992
9614279
3010291427
1420032

Source Documents

510(k) summary PDF

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