The following data is part of a premarket notification filed by D.r.g. with the FDA for Kamed Stethoscope.
Device ID | K890126 |
510k Number | K890126 |
Device Name: | KAMED STETHOSCOPE |
Classification | Stethoscope, Manual |
Applicant | D.R.G. P.O. BOX 1178 Mountainside, NJ 07092 |
Contact | Allan Korn |
Correspondent | Allan Korn D.R.G. P.O. BOX 1178 Mountainside, NJ 07092 |
Product Code | LDE |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-12 |
Decision Date | 1989-04-21 |