The following data is part of a premarket notification filed by Tdk Electronics Corporation Of America with the FDA for Tdk Medical Grade Cd-r.
| Device ID | K971848 |
| 510k Number | K971848 |
| Device Name: | TDK MEDICAL GRADE CD-R |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | TDK ELECTRONICS CORPORATION OF AMERICA 12 HARBOR PARK DR. Port Washington, NY 11050 |
| Contact | Koyo Yokoi |
| Correspondent | Koyo Yokoi TDK ELECTRONICS CORPORATION OF AMERICA 12 HARBOR PARK DR. Port Washington, NY 11050 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1997-08-15 |