The following data is part of a premarket notification filed by National Catheter Co. Div. Mallinckrodt with the FDA for Stethoscope With Temperature Sensor.
| Device ID | K791190 |
| 510k Number | K791190 |
| Device Name: | STETHOSCOPE WITH TEMPERATURE SENSOR |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | NATIONAL CATHETER CO. DIV. MALLINCKRODT 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 | 1979-06-26 |
| Decision Date | 1979-07-06 |