FDA.reportPublic FDA data

510(k) K242066

Device
iSage Rx
Applicant
Amalgam Rx, Inc.
510(k) number
K242066
Product code
NDC
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-21
Date received
2024-07-15
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
No

Applicant Contact#

Contact
Miller Andy
Address
1007 N. Orange St., Suite 400 Wilmington DE US 19801 19801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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