The following data is part of a premarket notification filed by Labarge, Inc. with the FDA for Esophageal Steth. Temp. Sensor.
| Device ID | K771411 |
| 510k Number | K771411 |
| Device Name: | ESOPHAGEAL STETH. TEMP. SENSOR |
| Classification | Stethoscope, Esophageal |
| Applicant | LABARGE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZW |
| CFR Regulation Number | 868.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-01 |
| Decision Date | 1977-09-23 |