The following data is part of a premarket notification filed by Maxtec, Llc with the FDA for Maxcap Ped And Maxcap Neo.
| Device ID | K182362 |
| 510k Number | K182362 |
| Device Name: | MaxCap Ped And MaxCap Neo |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Maxtec, LLC 2305 S 1070 W Salt Lake City, UT 84119 |
| Contact | Tammy Lavery |
| Correspondent | Paul Dryden Maxtec, LLC 2305 S 1070 W Salt Lake City, UT 84119 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-30 |
| Decision Date | 2019-05-23 |