The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Pedia-trake Cricothyrotomy Kit.
| Device ID | K840925 |
| 510k Number | K840925 |
| Device Name: | PEDIA-TRAKE CRICOTHYROTOMY KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | INTL. MEDICAL DEVICES LTD. 530 SECO RD. Monroeville, PA 15146 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-02 |
| Decision Date | 1984-05-02 |