The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Konan Clinic Microscope Clm-100-150.
Device ID | K844323 |
510k Number | K844323 |
Device Name: | KONAN CLINIC MICROSCOPE CLM-100-150 |
Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Contact | Van Arsdal |
Correspondent | Van Arsdal KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Product Code | HRM |
CFR Regulation Number | 878.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-07 |
Decision Date | 1984-11-21 |