The following data is part of a premarket notification filed by Medical Parameters, Inc. with the FDA for Esophageal Stethoscope.
| Device ID | K844444 |
| 510k Number | K844444 |
| Device Name: | ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal |
| Applicant | MEDICAL PARAMETERS, INC. 20 CABOT RD. Woburn, MA 01801 |
| Contact | Walter Maceachern |
| Correspondent | Walter Maceachern MEDICAL PARAMETERS, INC. 20 CABOT RD. Woburn, MA 01801 |
| Product Code | BZW |
| CFR Regulation Number | 868.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-16 |
| Decision Date | 1985-01-10 |