The following data is part of a premarket notification filed by Maxtec, Llc with the FDA for Maxo2me.
| Device ID | K153659 |
| 510k Number | K153659 |
| Device Name: | MaxO2ME |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MAXTEC, LLC 2305 South 1070 West Salt Lake City, UT 84111 9 |
| Contact | Jerald Wilson |
| Correspondent | Paul Dryden MAXTEC, LLC 2305 South 1070 West Salt Lake City, UT 84111 9 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853061006968 | K153659 | 000 |
| 00853061006951 | K153659 | 000 |
| 00853061006302 | K153659 | 000 |