The following data is part of a premarket notification filed by K & S Medicorp with the FDA for Transcor (tm) Radio-stethoscope.
Device ID | K854772 |
510k Number | K854772 |
Device Name: | TRANSCOR (TM) RADIO-STETHOSCOPE |
Classification | Stethoscope, Electronic |
Applicant | K & S MEDICORP 7860 S.W. 147 ST. Miami, FL 33158 |
Contact | Saltzman Md |
Correspondent | Saltzman Md K & S MEDICORP 7860 S.W. 147 ST. Miami, FL 33158 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-29 |
Decision Date | 1986-05-13 |