The following data is part of a premarket notification filed by Tiara Medical Systems, Inc. with the FDA for Tms Full Advantage Full Face Mask, Models Tms-2820, Tms-2830, Tms-2840.
| Device ID | K043382 |
| 510k Number | K043382 |
| Device Name: | TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | TIARA MEDICAL SYSTEMS, INC. 14414 DETROIT AVE, SUITE 205 Lakewood, OH 44107 |
| Contact | Geoffrey Sleeper |
| Correspondent | Geoffrey Sleeper TIARA MEDICAL SYSTEMS, INC. 14414 DETROIT AVE, SUITE 205 Lakewood, OH 44107 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-09 |
| Decision Date | 2005-01-19 |
| Summary: | summary |