The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Various Types Of: Keeler Magnatone 2 Stethoscopes:.
Device ID | K871369 |
510k Number | K871369 |
Device Name: | VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: |
Classification | Stethoscope, Manual |
Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Contact | Van Arsdale |
Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Product Code | LDE |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-07 |
Decision Date | 1987-09-24 |