The following data is part of a premarket notification filed by Monitor Mask, Inc. with the FDA for M1 Capnography Mask.
| Device ID | K133806 |
| 510k Number | K133806 |
| Device Name: | M1 CAPNOGRAPHY MASK |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MONITOR MASK, INC. 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Contact | Stuart R Goldman |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-12-16 |
| Decision Date | 2013-12-31 |
| Summary: | summary |