The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Argyle Esophageal Stethoscope.
Device ID | K790523 |
510k Number | K790523 |
Device Name: | ARGYLE ESOPHAGEAL STETHOSCOPE |
Classification | Stethoscope, Esophageal |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZW |
CFR Regulation Number | 868.1910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-15 |
Decision Date | 1979-03-27 |