The following data is part of a premarket notification filed by Maxtec, Inc. with the FDA for Maxo2+, Model A And Ae.
| Device ID | K040484 |
| 510k Number | K040484 |
| Device Name: | MAXO2+, MODEL A AND AE |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MAXTEC, INC. 6526 SOUTH COTTONWOOD ST. Salt Lake City, UT 84107 |
| Contact | Gordon R Roth |
| Correspondent | Gordon R Roth MAXTEC, INC. 6526 SOUTH COTTONWOOD ST. Salt Lake City, UT 84107 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-25 |
| Decision Date | 2004-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817770021735 | K040484 | 000 |
| 00853061006982 | K040484 | 000 |
| 00817770020660 | K040484 | 000 |
| 00817770020677 | K040484 | 000 |
| 00817770020684 | K040484 | 000 |
| 00817770020943 | K040484 | 000 |
| 00817770020950 | K040484 | 000 |
| 00817770020967 | K040484 | 000 |
| 00817770021018 | K040484 | 000 |
| 00817770021292 | K040484 | 000 |
| 00817770021308 | K040484 | 000 |
| 00817770021315 | K040484 | 000 |
| 00817770021346 | K040484 | 000 |
| 00817770021704 | K040484 | 000 |
| 00817770021711 | K040484 | 000 |
| 00817770021728 | K040484 | 000 |
| 00853061006937 | K040484 | 000 |