FDA.report

510(k) K231064

Device
ReddyPort Elbow
Applicant
Smd Manufacturing, LLC
510(k) number
K231064
Product code
MNS
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-13
Date received
2023-04-14
Regulation
868.5895
Classification name
Ventilator, Continuous, Non-Life-Supporting
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
Jared Spendlove
Address
918 S 500 W, Suite A Salt Lake City UT US 84101 84101

FDA Registration Numbers

Source Documents

510(k) summary PDF

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