The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for N-d0-sure.
| Device ID | K811185 |
| 510k Number | K811185 |
| Device Name: | N-D0-SURE |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | ACKRAD LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-29 |
| Decision Date | 1981-06-02 |