FDA.report

510(k) K260910

Device
EndoTool IV Cloud 1.0
Applicant
Glooko, Inc.
510(k) number
K260910
Product code
NDC
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-01
Date received
2026-03-19
Regulation
868.1890
Classification name
Calculator, Drug Dose
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Katherine Rojas
Address
579 University Ave. Palo Alto CA US 94301 94301

FDA Registration Numbers

Source Documents

510(k) summary PDF

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