The following data is part of a premarket notification filed by Disa Medintec with the FDA for Trachealator.
| Device ID | K211894 |
| 510k Number | K211894 |
| Device Name: | Trachealator |
| Classification | Bronchoscope Accessory |
| Applicant | DISA Medintec Stand 171, Northlands Business Park, Bush Telegraph Street Northriding Johannesburg, ZA 2169 |
| Contact | Michelle Nieuwoudt |
| Correspondent | Matthew Krueger Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2021-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009698450009 | K211894 | 000 |