The following data is part of a premarket notification filed by Acutronic Medical Systems Ag with the FDA for Trans- Circothyrotomy Device (acc. Ravussin).
| Device ID | K862436 |
| 510k Number | K862436 |
| Device Name: | TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | ACUTRONIC MEDICAL SYSTEMS AG KREUZSTRASSE 100 Jona-rapper Swril, CH 8645 |
| Contact | Ajai P Singh |
| Correspondent | Ajai P Singh ACUTRONIC MEDICAL SYSTEMS AG KREUZSTRASSE 100 Jona-rapper Swril, CH 8645 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-26 |
| Decision Date | 1986-11-03 |