The following data is part of a premarket notification filed by Konica Medical Corp. with the FDA for Cm & Cm Ds-7.
| Device ID | K963914 |
| 510k Number | K963914 |
| Device Name: | CM & CM DS-7 |
| Classification | Cassette, Radiographic Film |
| 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 | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-30 |
| Decision Date | 1997-10-08 |