The following data is part of a premarket notification filed by Smiths Medical with the FDA for Portex Emergency Cricothyroidotomy Kit.
| Device ID | K050166 |
| 510k Number | K050166 |
| Device Name: | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT |
| Classification | Needle, Emergency Airway |
| Applicant | SMITHS MEDICAL MILITARY ROAD Hythe, Kent, GB Ct 21 5bn |
| Contact | Christopher Turnbull |
| Correspondent | Christopher Turnbull SMITHS MEDICAL MILITARY ROAD Hythe, Kent, GB Ct 21 5bn |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-26 |
| Decision Date | 2005-05-26 |
| Summary: | summary |