The following data is part of a premarket notification filed by Medical Electronics Corp. with the FDA for Trachea/cuff Inflator W/pressure #583.
| Device ID | K831577 |
| 510k Number | K831577 |
| Device Name: | TRACHEA/CUFF INFLATOR W/PRESSURE #583 |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | MEDICAL ELECTRONICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-17 |
| Decision Date | 1983-07-07 |