The following data is part of a premarket notification filed by Truer Medical Inc. with the FDA for Esophageal Stethoscope.
| Device ID | K092716 |
| 510k Number | K092716 |
| Device Name: | ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | TRUER MEDICAL INC. 1050 N BATAVIA STREET Orange, CA 92867 |
| Contact | Tim Truitt |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-03 |
| Decision Date | 2009-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859290006106 | K092716 | 000 |
| 00859290006014 | K092716 | 000 |
| 00859290006021 | K092716 | 000 |
| 00859290006038 | K092716 | 000 |
| 00859290006045 | K092716 | 000 |
| 00859290006052 | K092716 | 000 |
| 00859290006069 | K092716 | 000 |
| 00859290006076 | K092716 | 000 |
| 00859290006083 | K092716 | 000 |
| 00859290006090 | K092716 | 000 |
| 00859290006007 | K092716 | 000 |