510(k) K240937

Device
AIM (N/A)
Applicant
Inventeur, LLC
510(k) number
K240937
Product code
CCK
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-16
Date received
2024-04-05
Regulation
868.1400
Classification name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Tariq Chaudhry
Address
16192 Coastal Hwy. Lewes DE US 19958 19958

FDA Registration Numbers

Source Documents

510(k) summary PDF

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