The following data is part of a premarket notification filed by Coast Medical, Inc. with the FDA for Disposable Esophageal Stethoscope.
| Device ID | K943495 |
| 510k Number | K943495 |
| Device Name: | DISPOSABLE ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | COAST MEDICAL, INC. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Contact | Douglass R Monogeon |
| Correspondent | Douglass R Monogeon COAST MEDICAL, INC. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-09-08 |