The following data is part of a premarket notification filed by Tiara Medical Systems, Inc. with the FDA for Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models Tms-2520, Tms 2530.
| Device ID | K012207 |
| 510k Number | K012207 |
| Device Name: | ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-07-23 |