The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Telemetric Stethoscope.
| Device ID | K882319 |
| 510k Number | K882319 |
| Device Name: | TELEMETRIC STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Ed Gillen |
| Correspondent | Ed Gillen VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-06 |
| Decision Date | 1988-08-02 |