510(k) K182362
K182362 is an FDA 510(k) premarket notification submitted by Maxtec, LLC for the device "MaxCap Ped and MaxCap Neo". The FDA issued a decision of Substantially Equivalent on May 23, 2019. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Maxtec, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2019
- Date Received
- August 30, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1400
- Review Panel
- AN
- Submission Type