Atlas FDA

Spectrum IQ Infusion System, Dose IQ Safety Software

FDA 510(k) clearance K173084 · decided 2018-05-11

Clearance details

K-number
K173084
Device name
Spectrum IQ Infusion System, Dose IQ Safety Software
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2017-09-29
Decision date
2018-05-11
Days to decision
224 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Baxter Spectrum IQ Infusion Pumps, Product code 3570009. recall (Z-0529-2022)Baxter Healthcare Corporation2022-01-29
Dose IQ Safety Software used with Spectrum IQ Infusion Pump recall (Z-2165-2021)Baxter Healthcare Corporation2021-08-11
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the co recall (Z-2110-2021)Baxter Healthcare Corporation2021-08-06
Spectrum IQ Infusion System with Dose IQ Safety Software recall (Z-0123-2021)Baxter Healthcare Corporation2020-10-22

PMA approvals by this applicant

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