The following data is part of a premarket notification filed by Sharn, Inc. with the FDA for Esophageal Stethoscope.
Device ID | K860558 |
510k Number | K860558 |
Device Name: | ESOPHAGEAL STETHOSCOPE |
Classification | Stethoscope, Esophageal |
Applicant | SHARN, INC. 1300 NORTH WESTSHORE BLVD. Tampa, FL 33607 |
Contact | Bruce A Tomlinson |
Correspondent | Bruce A Tomlinson SHARN, INC. 1300 NORTH WESTSHORE BLVD. Tampa, FL 33607 |
Product Code | BZW |
CFR Regulation Number | 868.1910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-14 |
Decision Date | 1986-04-01 |