MAXMIXING BLOCK
FDA 510(k) clearance K113232 · decided 2012-03-01
Clearance details
- K-number
- K113232
- Device name
- MAXMIXING BLOCK
- Applicant
- Maxtec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-02
- Decision date
- 2012-03-01
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- BZR
- Device class
- 2
- Regulation number
- 868.5330
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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| GMX Series Medical Air/Oxygen Blender (K142291) | Gentec (Shanghai) Corporation | 2015-05-19 |
| EQUINOX RELIEVE (K113687) | O-Two Medical Technologies, Inc. | 2012-04-30 |
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Recalls involving this device
No recalls on record reference this clearance.