The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hi-lo Temp Esophageal Stethoscope.
| Device ID | K811862 |
| 510k Number | K811862 |
| Device Name: | HI-LO TEMP ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521031740 | K811862 | 000 |
| 10884521031739 | K811862 | 000 |
| 30884521031726 | K811862 | 000 |
| 30884521031719 | K811862 | 000 |
| 20884521820927 | K811862 | 000 |
| 30884521820917 | K811862 | 000 |
| 20884521820903 | K811862 | 000 |
| 30884521820894 | K811862 | 000 |