The following data is part of a premarket notification filed by Maxtec, Llc with the FDA for Ultramaxo2 Oxygen Analyer.
| Device ID | K112402 |
| 510k Number | K112402 |
| Device Name: | ULTRAMAXO2 OXYGEN ANALYER |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MAXTEC, LLC 6526 Cottonwood St # 300 Salt Lake City, UT 84107 |
| Contact | Tammy Lavery |
| Correspondent | Tammy Lavery MAXTEC, LLC 6526 Cottonwood St # 300 Salt Lake City, UT 84107 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2011-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817770020998 | K112402 | 000 |
| 00817770020936 | K112402 | 000 |
| 00817770020929 | K112402 | 000 |
| 00841447100737 | K112402 | 000 |