The following data is part of a premarket notification filed by Transtracheal Systems with the FDA for Transtracheal Demand Oxygen Controller Model Doc-3000.
| Device ID | K982943 |
| 510k Number | K982943 |
| Device Name: | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 |
| Classification | Conserver, Oxygen |
| Applicant | TRANSTRACHEAL SYSTEMS 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis W Ward |
| Correspondent | Lewis W Ward TRANSTRACHEAL SYSTEMS 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-21 |
| Decision Date | 1999-07-12 |