The following data is part of a premarket notification filed by Tiara Medical Systems, Inc. with the FDA for Tms Comfort Series Nasal Cpap Mask.
| Device ID | K964092 |
| 510k Number | K964092 |
| Device Name: | TMS COMFORT SERIES NASAL CPAP MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | TIARA MEDICAL SYSTEMS, INC. 4220 W. 166TH ST. Oak Forrest, IL 60452 |
| Contact | Norbert E Cichon |
| Correspondent | Norbert E Cichon TIARA MEDICAL SYSTEMS, INC. 4220 W. 166TH ST. Oak Forrest, IL 60452 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-11 |
| Decision Date | 1997-07-31 |