The following data is part of a premarket notification filed by Novamed, Llc with the FDA for Lifesound Esophageal Stethoscope.
| Device ID | K062020 |
| 510k Number | K062020 |
| Device Name: | LIFESOUND ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | NOVAMED, LLC 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden NOVAMED, LLC 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 -2015 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-17 |
| Decision Date | 2006-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817499020211 | K062020 | 000 |
| 20817499020013 | K062020 | 000 |
| 20817499020020 | K062020 | 000 |
| 20817499020037 | K062020 | 000 |
| 20817499020044 | K062020 | 000 |
| 20817499020051 | K062020 | 000 |
| 20817499020068 | K062020 | 000 |
| 20817499020075 | K062020 | 000 |
| 20817499020204 | K062020 | 000 |
| 20817499020006 | K062020 | 000 |