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 |