The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Tracheal Tube/stethoscope.
Device ID | K842464 |
510k Number | K842464 |
Device Name: | TRACHEAL TUBE/STETHOSCOPE |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-25 |
Decision Date | 1984-07-06 |