The following data is part of a premarket notification filed by Maxtec, Inc. with the FDA for Flocap.
| Device ID | K133540 |
| 510k Number | K133540 |
| Device Name: | FLOCAP |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MAXTEC, INC. 6526 SOUTH COTTONWOOD ST. Salt Lake City, UT 84107 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MAXTEC, INC. 6526 SOUTH COTTONWOOD ST. Salt Lake City, UT 84107 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-18 |
| Decision Date | 2014-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817770021674 | K133540 | 000 |
| 00817770020813 | K133540 | 000 |
| 20817770020817 | K133540 | 000 |
| 10889483228371 | K133540 | 000 |
| 10889483228364 | K133540 | 000 |
| 10889483227022 | K133540 | 000 |
| 10889483227046 | K133540 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLOCAP 98729748 not registered Live/Pending |
Flow Software LLC 2024-09-03 |
![]() FLOCAP 85620510 4518329 Live/Registered |
VENTLAB, LLC 2012-05-09 |