The following data is part of a premarket notification filed by Tiara Medical Systems, Inc. with the FDA for Tms Snapp Soft Nasal Accessory For Positive Pressure, Models Tms-3020, Tms-3030 & Tms-3040.
| Device ID | K034053 |
| 510k Number | K034053 |
| Device Name: | TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 |
| 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 | 2003-12-30 |
| Decision Date | 2004-06-24 |
| Summary: | summary |