The following data is part of a premarket notification filed by Maxtec, Inc. with the FDA for Maxmixing Block.
| Device ID | K113232 |
| 510k Number | K113232 |
| Device Name: | MAXMIXING BLOCK |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | MAXTEC, INC. 6526 SOUTH COTTONWOOD ST. Salt Lake City, UT 84107 |
| Contact | Tammy Lavery |
| Correspondent | Tammy Lavery MAXTEC, INC. 6526 SOUTH COTTONWOOD ST. Salt Lake City, UT 84107 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-02 |
| Decision Date | 2012-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817770021827 | K113232 | 000 |
| 00853061006050 | K113232 | 000 |
| 00853061006067 | K113232 | 000 |
| 00853061006135 | K113232 | 000 |
| 00853061006142 | K113232 | 000 |
| 00853061006159 | K113232 | 000 |
| 00817770020783 | K113232 | 000 |
| 00817770020790 | K113232 | 000 |
| 00817770020806 | K113232 | 000 |
| 00853061006036 | K113232 | 000 |