The following data is part of a premarket notification filed by Transtracheal Systems with the FDA for Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000.
| Device ID | K981078 |
| 510k Number | K981078 |
| Device Name: | TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 |
| Classification | Generator, Oxygen, Portable |
| Applicant | TRANSTRACHEAL SYSTEMS 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward TRANSTRACHEAL SYSTEMS 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-24 |
| Decision Date | 1998-07-23 |