The following data is part of a premarket notification filed by Merlin Engineering Works, Inc. with the FDA for Downscan Lt.
| Device ID | K974882 |
| 510k Number | K974882 |
| Device Name: | DOWNSCAN LT |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | MERLIN ENGINEERING WORKS, INC. 1888 EMBARCADERO RD. Palo Alto, CA 94303 |
| Contact | Gerald Engbretson |
| Correspondent | Gerald Engbretson MERLIN ENGINEERING WORKS, INC. 1888 EMBARCADERO RD. Palo Alto, CA 94303 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-30 |
| Decision Date | 1998-05-22 |
| Summary: | summary |