The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Weiss Emergency Airway System.
| Device ID | K790650 |
| 510k Number | K790650 |
| Device Name: | WEISS EMERGENCY AIRWAY SYSTEM |
| Classification | Needle, Emergency Airway |
| Applicant | INTL. MEDICAL DEVICES LTD. 530 SECO RD. Monroeville, PA 15146 |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-03 |
| Decision Date | 1979-06-27 |