The following data is part of a premarket notification filed by Maxtec, Llc with the FDA for Maxblend 2, Maxblend Lite.
| Device ID | K161718 |
| 510k Number | K161718 |
| Device Name: | MaxBlend 2, MaxBlend Lite |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | Maxtec, LLC 2305 South 1070 West Salt Lake City, UT 84119 |
| Contact | Bruce Brierley |
| Correspondent | Paul Dryden Maxtec, LLC 2305 South 1070 West Salt Lake City, UT 84119 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-22 |
| Decision Date | 2016-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817770021797 | K161718 | 000 |
| 00817770021216 | K161718 | 000 |
| 00853061006814 | K161718 | 000 |
| 00853061006791 | K161718 | 000 |
| 00853061006777 | K161718 | 000 |
| 00853061006753 | K161718 | 000 |
| 00853061006388 | K161718 | 000 |
| 00853061006371 | K161718 | 000 |
| 00853061006333 | K161718 | 000 |
| 00853061006326 | K161718 | 000 |
| 00853061006319 | K161718 | 000 |
| 00853061006265 | K161718 | 000 |
| 00853061006043 | K161718 | 000 |
| 00817770021223 | K161718 | 000 |
| 00817770021261 | K161718 | 000 |
| 00817770021780 | K161718 | 000 |
| 00817770021773 | K161718 | 000 |
| 00817770021766 | K161718 | 000 |
| 00817770021759 | K161718 | 000 |
| 00817770021742 | K161718 | 000 |
| 00817770021520 | K161718 | 000 |
| 00817770021513 | K161718 | 000 |
| 00817770021506 | K161718 | 000 |
| 00817770021490 | K161718 | 000 |
| 00817770021483 | K161718 | 000 |
| 00817770021391 | K161718 | 000 |
| 00817770021384 | K161718 | 000 |
| 00817770025672 | K161718 | 000 |