The following data is part of a premarket notification filed by Schering Corp. with the FDA for Differential Stethoscope W/dual Heads; Stereoscope.
Device ID | K860473 |
510k Number | K860473 |
Device Name: | DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE |
Classification | Stethoscope, Manual |
Applicant | SCHERING CORP. 2000 GALLOPING HILL RD. Kenilworth, NJ 07033 |
Contact | Alexander Giaquinto |
Correspondent | Alexander Giaquinto SCHERING CORP. 2000 GALLOPING HILL RD. Kenilworth, NJ 07033 |
Product Code | LDE |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-06 |
Decision Date | 1986-08-14 |