The following data is part of a premarket notification filed by Konica Medical Corp. with the FDA for Konica Kfdr-s.
Device ID | K896739 |
510k Number | K896739 |
Device Name: | KONICA KFDR-S |
Classification | Digitizer, Image, Radiological |
Applicant | KONICA MEDICAL CORP. 757 THIRD AVE. New York, NY 10017 |
Contact | Jordan B Bierman |
Correspondent | Jordan B Bierman KONICA MEDICAL CORP. 757 THIRD AVE. New York, NY 10017 |
Product Code | LMA |
CFR Regulation Number | 892.2030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-30 |
Decision Date | 1990-04-30 |