The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Esophageal Stethoscope With Thermistor.
| Device ID | K862672 |
| 510k Number | K862672 |
| Device Name: | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Contact | Blackwood Hyams |
| Correspondent | Blackwood Hyams INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-14 |
| Decision Date | 1986-10-27 |