The following data is part of a premarket notification filed by Konica Medical Corp. with the FDA for Md100 & Mm150.
| Device ID | K963913 |
| 510k Number | K963913 |
| Device Name: | MD100 & MM150 |
| Classification | Screen, Intensifying, Radiographic |
| Applicant | KONICA MEDICAL CORP. THE CHRYSLER BUILDING 405 LEXINGTON AVENUE New York, NY 10174 |
| Contact | Russell D Munves |
| Correspondent | Russell D Munves KONICA MEDICAL CORP. THE CHRYSLER BUILDING 405 LEXINGTON AVENUE New York, NY 10174 |
| Product Code | EAM |
| CFR Regulation Number | 892.1960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-30 |
| Decision Date | 1997-10-08 |