The following data is part of a premarket notification filed by Tiara Medical Systems, Inc. with the FDA for Tiara Snapp X Soft Nasal Accessory For Positive Pressure, Models Tms-3020, Tms-3030, Tms- 3040, Tms-3050.
| Device ID | K051583 |
| 510k Number | K051583 |
| Device Name: | TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 |
| 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 | 2005-06-15 |
| Decision Date | 2005-11-04 |
| Summary: | summary |