The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Digicam Lhp (video Interface Option).
| Device ID | K895668 |
| 510k Number | K895668 |
| Device Name: | DIGICAM LHP (VIDEO INTERFACE OPTION) |
| Classification | Camera, Multi Format, Radiological |
| Applicant | SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Contact | W Henkelman |
| Correspondent | W Henkelman SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1989-11-15 |