510(k) K232793
- Device
- Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- Applicant
- Zevex, Inc.
- 510(k) number
- K232793
- Product code
- FRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-17
- Date received
- 2023-09-11
- 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
- Christopher Dodge
- Address
- 4314 Zevex Park Ln., Salt Lake City UT US 84123 84123
FDA Registration Numbers
- 2521402
- 3011883032
- 1423507
- 3006575795
- 1416980
- 2650143
- 1061124
- 3000240707
- 1054713
- 3010291427
- 3008132411
- 9615908
- 2032098
- 1018470
- 2027804
- 1220973
- 3000204189
- 1219702
- 3013557562
- 1125615
- 3003879246
- 1319660
- 1423537
- 1000163068
- 3016798778
- 3012307300
- 3024122953
- 3013298431
- 3017636737
- 1045254
- 3008692839
- 3012302888
- 3012337868
- 9681819
- 3009456923
- 3008810357
- 3005382983
- 9710049
- 3006158088
- 2032227
- 3004530184
- 3005627859
- 3010564249
- 3015158050
- 1066270
- 3006534321
- 9614279
- 3002808022
- 9680741
- 3008058400
- 3013319212
- 3016509758
- 3013722099
- 3029973819
- 1058584
- 3004548776
- 3007738736
- 3008570882
- 3003927385
- 3018229072
- 1526611
- 2022994
- 2024064
- 1723170
- 1713468
- 2029015
- 3004906872
- 1121996
- 1928237
- 2411512
- 1319639
- 3004112621
- 1420032
- 9615050
- 3010082909
- 3005778453
- 9610825
- 3014732157
- 2024022
- 1314492
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- 3003144120
- 1722139
- 3042027705
- 3005053560
- 3011270181
- 3004491689
- 2030624
- 3010432890
- 1720929
- 2523676
- 3012494290
- 1921846
- 3002879653
- 3013764800
- 2032112
- 2016493
- 3010273872
- 3010293992
- 1123137
- 1220477
- 3015972753
- 1047843
- 3008513006
- 1055927
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- 3017907746
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- 3015276780
- 3003098013
- 9617594
- 2523167
- 3005700264
- 2032862
- 9617787
- 2011171
- 3004056159
- 1219602
- 9617604
- 2528981
- 3018094310
- 1320894
- 3015192982
- 3010381606
Source Documents
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| K230083 | SAFIRA | Medovate Limited | 2023-10-31 |