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 |