MaxCap Ped and MaxCap Neo
FDA 510(k) K182362 · Maxtec, LLC
510(k) numberK182362
Submission
- Device name
- MaxCap Ped and MaxCap Neo
- Applicant
- Maxtec, LLC
Salt Lake City, UT, US - Received
- August 30, 2018
- Decision date
- May 23, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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Questions and answers
When was MaxCap Ped and MaxCap Neo cleared by the FDA?
MaxCap Ped and MaxCap Neo (K182362) received a 510(k) decision of Substantially Equivalent on May 23, 2019, 266 days after the submission was received.
What is the product code of K182362?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.